This document provides information on a workshop titled "Navigating the requirements of a modern QC Microbiology Laboratory" that will be held on November 15th, 2017. The workshop will introduce approaches for blending traditional and cutting-edge microbiology methodologies both in the laboratory and for manufacturing monitoring programs. It will also provide practical solutions for common laboratory issues and expectations for building quality into pharmaceutical products. The workshop will be led by Vanessa Vasadi-Figueroa and Robert Ferer and cover topics such as modernizing laboratories, real-time release testing, data integrity, and training new talent.
SMi Group's Pharmaceutical Microbiology USA 2017 conferenceDale Butler
This document provides information on the Pharmaceutical Microbiology USA conference happening on June 7-9, 2017 in San Diego. The conference will address current challenges in sterility assurance, environmental monitoring, and rapid microbial methods. It will feature presentations and panel discussions from industry experts on topics like challenges in microbial control, environmental monitoring trends, rapid microbial testing validation, data integrity, and contamination issues. Attendees can choose from pre-conference workshops on technologies for monitoring contamination control or microbial required use for terminal sterilization. The conference aims to evaluate the latest trends and opportunities in microbial control for pharmaceutical manufacturing.
SMi Group's Pharmaceutical Microbiology West Coast 2019 conferenceDale Butler
This document provides information about the Pharmaceutical Microbiology West Coast conference taking place June 4-6, 2019 in San Diego, CA. The conference will focus on bolstering contamination control strategies and maintaining microbial quality in pharmaceutical manufacturing. Over the two and a half days, the conference will include keynote speakers from major pharmaceutical companies discussing topics like contamination control, endotoxin testing, environmental monitoring, and strategies for special drug products. There will also be two pre-conference workshops on June 4th focusing on holistic approaches to microbial contamination control and endotoxins/impurities. The conference is aimed at microbiology, quality control, and manufacturing professionals working to ensure microbial safety in pharmaceutical and biotech facilities and products.
SMi Group's Pharma Microbiology East Coast 2019 - updated Feb 2019Dale Butler
This document provides information about the Pharmaceutical Microbiology East Coast conference taking place from April 10-12, 2019 in Boston, USA. The conference will discuss best practices and techniques for tackling microbial control challenges in the pharmaceutical industry. Over the two-day conference and optional workshops on the third day, topics will include regulatory considerations, environmental monitoring, rapid microbial methods, sterility assurance, case studies, and risk mitigation strategies. Speakers will represent major pharmaceutical companies and provide insights on the latest industry issues and solutions. Attendees can gain expertise on key microbiological topics relevant for pharmaceutical manufacturing and product development.
SMi will host the 7th Pharmaceutical Microbiology West Coast conference on June 8-9, 2017 in San Diego, USA. The conference will address current challenges in sterility assurance, environmental monitoring, and rapid microbial methods. Over the two days, experts from companies like GSK, Amgen, Janssen, and Takeda will discuss topics like environmental monitoring trends and data analysis, challenges in endotoxin testing and sterility assurance, case studies on contamination control, and the validation and use of rapid microbial methods. Workshops on the day before will cover technologies for monitoring contamination control and case studies, as well as microbial requirements for terminal sterilization.
SMi proudly presents due to the huge success of our Pharmaceutical Microbiology UK event the launch of SMi's Pharmaceutical Microbiology USA Conference in San Diego on 8th and 9th June 2017. Latest reports show that global rapid microbiology tests market to reach a net worth USD 19.5 Bn by 2022.* With the field growing at such a rapid rate SMi would like to take this opportunity to invite you to join us as we address the hot topics of the industry such as RMM, low endotoxin recovery, risk assessment and many more! With the forthcoming changes to annexe 1, take this opportunity to hear direct regulatory feedback and benchmark your strategies amongst industry peers. Our 2 day event will include presentations from both regulatory and industry experts sharing recent case studies and developing trends in the field of pharmaceutical microbiology
Neeta Shah is a microbiologist with over 25 years of experience in food and pharmaceutical microbiology, quality control, and project management. She has worked in various roles such as a senior microbiologist and laboratory leader at SGS North America, as a consultant for a new microbiology lab setup at Blue Bonnet Nutraceuticals, and as a corporate microbiologist at Solgar Vitamins. She has expertise in areas like food microbiology, environmental monitoring, validation testing, quality assurance, and training.
5th Annual Pre-Filled Syringes East CoastTeri Arri
This document provides an agenda for the Pre-Filled Syringes East Coast conference taking place on April 10-12, 2018 in Boston. The agenda includes workshops on human factors for connected drug delivery systems and design considerations for drug delivery outside the clinic on April 10th. The main conference on April 11-12th will feature sessions on regulatory updates, manufacturing challenges and solutions, trends toward biologics, and human factors considerations. Speakers will address topics such as syringe filling of high concentration formulations, safety evaluation of leachables, quality by design principles, and the future of digital monitoring biomarkers.
SMi Group's Pharmaceutical Microbiology West Coast 2020 conferenceDale Butler
This document provides information on the Pharmaceutical Microbiology West Coast conference happening June 17-19, 2020 in San Diego. It outlines the chairs, speakers, highlights and agenda for the event. The conference will focus on novel approaches and best practices for tackling current industry contamination control challenges, and will include sessions on contamination control, guidance and regulations, detection and identification methods, and supporting pharmaceutical facilities and novel therapeutics. There will also be an optional pre-conference workshop on data integrity in environmental monitoring.
SMi Group's Pharmaceutical Microbiology USA 2017 conferenceDale Butler
This document provides information on the Pharmaceutical Microbiology USA conference happening on June 7-9, 2017 in San Diego. The conference will address current challenges in sterility assurance, environmental monitoring, and rapid microbial methods. It will feature presentations and panel discussions from industry experts on topics like challenges in microbial control, environmental monitoring trends, rapid microbial testing validation, data integrity, and contamination issues. Attendees can choose from pre-conference workshops on technologies for monitoring contamination control or microbial required use for terminal sterilization. The conference aims to evaluate the latest trends and opportunities in microbial control for pharmaceutical manufacturing.
SMi Group's Pharmaceutical Microbiology West Coast 2019 conferenceDale Butler
This document provides information about the Pharmaceutical Microbiology West Coast conference taking place June 4-6, 2019 in San Diego, CA. The conference will focus on bolstering contamination control strategies and maintaining microbial quality in pharmaceutical manufacturing. Over the two and a half days, the conference will include keynote speakers from major pharmaceutical companies discussing topics like contamination control, endotoxin testing, environmental monitoring, and strategies for special drug products. There will also be two pre-conference workshops on June 4th focusing on holistic approaches to microbial contamination control and endotoxins/impurities. The conference is aimed at microbiology, quality control, and manufacturing professionals working to ensure microbial safety in pharmaceutical and biotech facilities and products.
SMi Group's Pharma Microbiology East Coast 2019 - updated Feb 2019Dale Butler
This document provides information about the Pharmaceutical Microbiology East Coast conference taking place from April 10-12, 2019 in Boston, USA. The conference will discuss best practices and techniques for tackling microbial control challenges in the pharmaceutical industry. Over the two-day conference and optional workshops on the third day, topics will include regulatory considerations, environmental monitoring, rapid microbial methods, sterility assurance, case studies, and risk mitigation strategies. Speakers will represent major pharmaceutical companies and provide insights on the latest industry issues and solutions. Attendees can gain expertise on key microbiological topics relevant for pharmaceutical manufacturing and product development.
SMi will host the 7th Pharmaceutical Microbiology West Coast conference on June 8-9, 2017 in San Diego, USA. The conference will address current challenges in sterility assurance, environmental monitoring, and rapid microbial methods. Over the two days, experts from companies like GSK, Amgen, Janssen, and Takeda will discuss topics like environmental monitoring trends and data analysis, challenges in endotoxin testing and sterility assurance, case studies on contamination control, and the validation and use of rapid microbial methods. Workshops on the day before will cover technologies for monitoring contamination control and case studies, as well as microbial requirements for terminal sterilization.
SMi proudly presents due to the huge success of our Pharmaceutical Microbiology UK event the launch of SMi's Pharmaceutical Microbiology USA Conference in San Diego on 8th and 9th June 2017. Latest reports show that global rapid microbiology tests market to reach a net worth USD 19.5 Bn by 2022.* With the field growing at such a rapid rate SMi would like to take this opportunity to invite you to join us as we address the hot topics of the industry such as RMM, low endotoxin recovery, risk assessment and many more! With the forthcoming changes to annexe 1, take this opportunity to hear direct regulatory feedback and benchmark your strategies amongst industry peers. Our 2 day event will include presentations from both regulatory and industry experts sharing recent case studies and developing trends in the field of pharmaceutical microbiology
Neeta Shah is a microbiologist with over 25 years of experience in food and pharmaceutical microbiology, quality control, and project management. She has worked in various roles such as a senior microbiologist and laboratory leader at SGS North America, as a consultant for a new microbiology lab setup at Blue Bonnet Nutraceuticals, and as a corporate microbiologist at Solgar Vitamins. She has expertise in areas like food microbiology, environmental monitoring, validation testing, quality assurance, and training.
5th Annual Pre-Filled Syringes East CoastTeri Arri
This document provides an agenda for the Pre-Filled Syringes East Coast conference taking place on April 10-12, 2018 in Boston. The agenda includes workshops on human factors for connected drug delivery systems and design considerations for drug delivery outside the clinic on April 10th. The main conference on April 11-12th will feature sessions on regulatory updates, manufacturing challenges and solutions, trends toward biologics, and human factors considerations. Speakers will address topics such as syringe filling of high concentration formulations, safety evaluation of leachables, quality by design principles, and the future of digital monitoring biomarkers.
SMi Group's Pharmaceutical Microbiology West Coast 2020 conferenceDale Butler
This document provides information on the Pharmaceutical Microbiology West Coast conference happening June 17-19, 2020 in San Diego. It outlines the chairs, speakers, highlights and agenda for the event. The conference will focus on novel approaches and best practices for tackling current industry contamination control challenges, and will include sessions on contamination control, guidance and regulations, detection and identification methods, and supporting pharmaceutical facilities and novel therapeutics. There will also be an optional pre-conference workshop on data integrity in environmental monitoring.
This document provides an agenda for the 6th Annual Diagnostic Quality Assurance conference to be held September 14-15 in Alexandria, VA. The conference will focus on quality assurance practices for diagnostic tests, including risk management, regulatory compliance, and process improvement. It lists distinguished industry presenters who will discuss topics such as preparing for and responding to FDA audits, global quality requirements, laboratory developed tests, and developing quality management systems. The agenda also outlines sessions on root cause analysis, document management, and selecting quality management databases.
India's first Int'l Conference on Best Practices in Pharma Microbiology Biocon
This is the first time that Pharmig, an international Pharmaceutical Microbiology think tank based out of the UK is organizing a conference on the "Best Practices in Pharma Microbiology" for the first time in India. You can register
by sending an email to maxine@pharmig.org.uk. For booking a seat for the conference, please visit: http://bit.ly/1J4gtLh
Hira Aslam is a performance-driven scientist with extensive experience working under FDA, ISO, ASTM and cGMP standards. She has a bachelor's degree in biology from Georgia Gwinnett College and has worked as a scientist at Ethicon since 2014, where she performs various tests on sutures including infrared spectroscopy, gas chromatography, and chemical assays. She also has experience as a microbiologist, pharmacy technician, and cashier. Hira has received several awards for her work in test method validation, water testing implementation, and protocol handling.
SMi Group's 3rd annual Prefilled Syringes East Coast 2016Dale Butler
This document provides information on the 3rd Annual Conference and Exhibition on Pre-Filled Syringes East Coast, taking place April 25-26, 2016 in Iselin, New Jersey. The conference will focus on key topics for pre-filled syringes (PFS) including eliminating extractables and leachables, incorporating human factors engineering, and the latest technologies for combination products, sterilization, and more. There will also be two half-day post-conference workshops on April 27th on human factors considerations for PFS development and regulatory submissions, as well as combination rule and CMC considerations for PFS and autoinjectors. The expert speaker panel will represent leading pharmaceutical companies. Attendees can
This document is a resume for A.Gopalakrishna seeking a position in quality assurance or research and development in the pharmaceutical sector. He has over 3 years of experience in analytical R&D and 7 years in bioanalytical work. Currently he works as an Associate Scientist at G.V.K. Biosciences Pvt Ltd in Hyderabad. His expertise includes method development, validation, analysis of samples, and ensuring compliance with regulations like USFDA 21 CFR Part 11. He has experience with various analytical instruments and software.
1) The document announces a training session on Good Manufacturing Practices (GMP) of the 21st century to be held on April 4th, 2021. It discusses how GMP standards have evolved over time to focus more on product development, process understanding and control strategies.
2) GMP via a quality management system is important for ensuring drug quality and preventing errors, as testing a small sample cannot guarantee the quality of an entire batch. Advances in technology are reshaping GMP requirements.
3) The training methodology will include tutorials, interactive discussions, and real-world case studies to describe regulatory expectations and keep learning objectives aligned. Participants will be assessed in real-time.
This document summarizes a presentation on pharmaceutical quality given at a PPE conference on August 25, 2020. It notes that the pharmaceutical industry in the country is dependent on imports for knowledge, technology, equipment, and materials. It discusses challenges like quality concerns, import alerts, and knowledge crises. It emphasizes that pharmaceutical quality depends on the quality of development and effectiveness of quality management systems. The presentation argues that to ensure quality, errors of omission and commission must be eliminated through quality by design and standard operating procedures. It concludes that leadership should focus on developing others and facilitating continual improvement rather than just aiming for minimum standards.
The document advertises the 8th annual Pre-Filled Syringes Americas conference and exhibition taking place from March 31st to April 2nd, 2014 in Iselin, New Jersey. The conference will bring together over 85 key decision makers from leading biotechnology and pharmaceutical companies to discuss developments in pre-filled syringes and injection devices over the course of two days of presentations, panel discussions, and workshops. Attendees will have the opportunity to network with industry leaders, evaluate solutions from exhibitors, and return to their businesses with the information and contacts needed to make decisions for their products.
Hear from a selection of carefully handpicked keynote addresses and case studies presented by big pharma such as Genentech, Allergan, Medimmune and Roche as well leading industry KOL's including Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon + more!
Mobilus Health provides mobile rapid molecular testing solutions and services to bring accurate, high-quality COVID-19 testing closer to patients. Their solution includes a turnkey mobile BSL-2 laboratory equipped for on-site molecular testing with results available in under 90 minutes. They also offer a rapid molecular COVID detection kit that uses a simple, low-cost isothermal assay directly on raw samples to produce highly accurate results comparable to RT-PCR tests in under 90 minutes. Mobilus Health aims to enable better medical decisions through low-cost and convenient testing that saves lives.
Anthony Polomene has over 20 years of experience in biopharmaceutical technical services including manufacturing process development, improvement, validation, and interaction with regulatory agencies. He is currently a Manager of Technical Services at Pfizer in Pearl River, New York, where he has led projects that optimized manufacturing processes, increased yields, and reduced cleaning times and investigations. Polomene has extensive experience developing and validating manufacturing equipment, processes, and analytical methods across multiple drug products and presentations.
This document announces a professional development session on the pharmaceuticals dashboard for 2021. It will discuss topics like uncertainty in quality, the future of manufacturing and regulations, and competitiveness with trade barriers. The session aims to help professionals mature their skills and align with emerging expectations. It will use tutorials, discussions, examples and case studies. Participant assessment will be confidential. The session facilitators have extensive regulatory experience in Pakistan and international agencies. It will be held on December 19th in Karachi with a small group size.
Michael Buckley has over 25 years of experience in biotech developing monoclonal antibodies and antibody drug conjugates for oncology and immunology indications. He has held leadership roles at multiple biotech companies, directing preclinical and clinical development programs. Currently, he works as an independent consultant focusing on preclinical development and manufacturing of biologics from Phase I through commercial stage.
Focused Chemical/Microbiological technician highly effective at following USP methods and GMP practices with pharmaceutical and medical device experience.
Chemist accomplished in GC, HPLC, analytical and assay methods used on raw material and finished products to assure the quality and purity of products. Certified in Clinical Trials and Drug Development and worked side by side a chemical formulator R&D chemist for 3 years. Coordinated process validation procedures, stability program, chemical waste management system, calibration program, laboratory set up, ordering and SOP procedural writing.
Versed Microbiological surface and air quality testing, process validation, microbiological identification, trending, tracking, gram staining techniques and microbiological morphology. Certified in Pharmaceutical Microbiology.
1) The document summarizes a training session on Good Manufacturing Practices (GMP) of the 21st Century that focused on continuous manufacturing, data sciences, machine learning, and real time release.
2) It discusses that traditional quality practices are no longer sufficient and that transformation is needed to address increasing complexity and uncertainty in pharmaceutical manufacturing.
3) The document questions whether one-time process validation on 3 batches and a single bioavailability/bioequivalence study are sufficient to assure quality over a product's lifecycle.
PT SGS Indonesia is a premier provider of certification, testing, auditing, and training services in Indonesia. It operates environmental testing laboratories and provides services to sectors like mining, oil and gas, consumer products, and government. SGS offers audit, certification, and advisory services to help customers improve processes and attain sustainability. It has expertise across many disciplines relevant to environmental and health baseline studies. The document outlines SGS's proposed scope of work, which includes stakeholder engagement, auditing service providers, data validation, project management, and secure data storage. Contact information is provided for further discussion.
This document provides an introduction and overview of a training session on Good Manufacturing Practices (GMP) for the 21st century. It notes that the presentation will reflect the presenter's views and is not meant to represent any official policies. Examples of recent drug contamination and mix-ups are presented to illustrate the importance of GMP in ensuring consistent quality, preventing contamination and mix-ups. GMP is described as a set of regulatory methods to inspect manufacturing practices to protect the integrity and quality of products intended for human use and ensure they are consistently produced and controlled.
SMi Group's Prefilled Syringes East Coast 2018 conferenceDale Butler
This document summarizes a two-day conference on pre-filled syringes taking place in Boston on April 10-11, 2018. The conference will include two pre-conference workshops on human factors for connected drug delivery systems and design considerations for drug delivery outside the clinic. The main conference will focus on challenges and solutions for PFS manufacturing and processes, integrating quality by design principles, and trends toward increasing biologics and their implications for PFS. It will feature speakers from major pharmaceutical companies and include panel discussions on challenges of biologics delivery and PFS development.
This document summarizes a presentation on quality metrics and culture given at Habib University in Karachi. It discusses key quality metrics like lot acceptance rate, product complaint rate, and CAPA effectiveness. It also identifies attributes of a strong quality culture like leadership emphasis, message credibility, peer involvement, and employee ownership. Finally, it stresses that quality is everyone's responsibility and a mature quality system relies on systems thinking and a culture that prioritizes quality and continuous improvement.
SMi Group's Pharmaceutical Microbiology East Coast 2019 Dale Butler
This document provides information on the Pharmaceutical Microbiology East Coast conference taking place from April 10-11, 2019 in Boston, USA. It includes details on registration, chairpersons, key speakers and their topics. The conference will discuss challenges in pharmaceutical microbiology such as regulatory changes, environmental monitoring, rapid methods and sterility assurance. There will also be workshops on April 12th on mold contamination challenges and microbiological control using vapor phase hydrogen peroxide bio-decontamination. The event is aimed at professionals working in pharmaceutical microbiology.
Pharmaceutical Microbiology West Coast 2018Dale Butler
The document outlines the agenda for the 2nd Annual Pharmaceutical Microbiology West Coast conference on June 7-8, 2018 in San Diego. The conference will focus on key challenges and developments in pharmaceutical microbiology, with sessions on environmental monitoring, rapid methods, data integrity, aseptic processing, regulatory updates, and microbial identification. Speakers will present case studies and discuss issues like microbiological deviations, contamination control, disinfectant efficacy testing, and applying pharmaceutical microbiology technologies to other fields like human diagnostics. Workshops on June 6 will address risk-based environmental monitoring and microbial contamination control technologies.
This document provides an agenda for the 6th Annual Diagnostic Quality Assurance conference to be held September 14-15 in Alexandria, VA. The conference will focus on quality assurance practices for diagnostic tests, including risk management, regulatory compliance, and process improvement. It lists distinguished industry presenters who will discuss topics such as preparing for and responding to FDA audits, global quality requirements, laboratory developed tests, and developing quality management systems. The agenda also outlines sessions on root cause analysis, document management, and selecting quality management databases.
India's first Int'l Conference on Best Practices in Pharma Microbiology Biocon
This is the first time that Pharmig, an international Pharmaceutical Microbiology think tank based out of the UK is organizing a conference on the "Best Practices in Pharma Microbiology" for the first time in India. You can register
by sending an email to maxine@pharmig.org.uk. For booking a seat for the conference, please visit: http://bit.ly/1J4gtLh
Hira Aslam is a performance-driven scientist with extensive experience working under FDA, ISO, ASTM and cGMP standards. She has a bachelor's degree in biology from Georgia Gwinnett College and has worked as a scientist at Ethicon since 2014, where she performs various tests on sutures including infrared spectroscopy, gas chromatography, and chemical assays. She also has experience as a microbiologist, pharmacy technician, and cashier. Hira has received several awards for her work in test method validation, water testing implementation, and protocol handling.
SMi Group's 3rd annual Prefilled Syringes East Coast 2016Dale Butler
This document provides information on the 3rd Annual Conference and Exhibition on Pre-Filled Syringes East Coast, taking place April 25-26, 2016 in Iselin, New Jersey. The conference will focus on key topics for pre-filled syringes (PFS) including eliminating extractables and leachables, incorporating human factors engineering, and the latest technologies for combination products, sterilization, and more. There will also be two half-day post-conference workshops on April 27th on human factors considerations for PFS development and regulatory submissions, as well as combination rule and CMC considerations for PFS and autoinjectors. The expert speaker panel will represent leading pharmaceutical companies. Attendees can
This document is a resume for A.Gopalakrishna seeking a position in quality assurance or research and development in the pharmaceutical sector. He has over 3 years of experience in analytical R&D and 7 years in bioanalytical work. Currently he works as an Associate Scientist at G.V.K. Biosciences Pvt Ltd in Hyderabad. His expertise includes method development, validation, analysis of samples, and ensuring compliance with regulations like USFDA 21 CFR Part 11. He has experience with various analytical instruments and software.
1) The document announces a training session on Good Manufacturing Practices (GMP) of the 21st century to be held on April 4th, 2021. It discusses how GMP standards have evolved over time to focus more on product development, process understanding and control strategies.
2) GMP via a quality management system is important for ensuring drug quality and preventing errors, as testing a small sample cannot guarantee the quality of an entire batch. Advances in technology are reshaping GMP requirements.
3) The training methodology will include tutorials, interactive discussions, and real-world case studies to describe regulatory expectations and keep learning objectives aligned. Participants will be assessed in real-time.
This document summarizes a presentation on pharmaceutical quality given at a PPE conference on August 25, 2020. It notes that the pharmaceutical industry in the country is dependent on imports for knowledge, technology, equipment, and materials. It discusses challenges like quality concerns, import alerts, and knowledge crises. It emphasizes that pharmaceutical quality depends on the quality of development and effectiveness of quality management systems. The presentation argues that to ensure quality, errors of omission and commission must be eliminated through quality by design and standard operating procedures. It concludes that leadership should focus on developing others and facilitating continual improvement rather than just aiming for minimum standards.
The document advertises the 8th annual Pre-Filled Syringes Americas conference and exhibition taking place from March 31st to April 2nd, 2014 in Iselin, New Jersey. The conference will bring together over 85 key decision makers from leading biotechnology and pharmaceutical companies to discuss developments in pre-filled syringes and injection devices over the course of two days of presentations, panel discussions, and workshops. Attendees will have the opportunity to network with industry leaders, evaluate solutions from exhibitors, and return to their businesses with the information and contacts needed to make decisions for their products.
Hear from a selection of carefully handpicked keynote addresses and case studies presented by big pharma such as Genentech, Allergan, Medimmune and Roche as well leading industry KOL's including Nemera, Nipro PharmaPackaging, Terumo, Worrell, Zeon + more!
Mobilus Health provides mobile rapid molecular testing solutions and services to bring accurate, high-quality COVID-19 testing closer to patients. Their solution includes a turnkey mobile BSL-2 laboratory equipped for on-site molecular testing with results available in under 90 minutes. They also offer a rapid molecular COVID detection kit that uses a simple, low-cost isothermal assay directly on raw samples to produce highly accurate results comparable to RT-PCR tests in under 90 minutes. Mobilus Health aims to enable better medical decisions through low-cost and convenient testing that saves lives.
Anthony Polomene has over 20 years of experience in biopharmaceutical technical services including manufacturing process development, improvement, validation, and interaction with regulatory agencies. He is currently a Manager of Technical Services at Pfizer in Pearl River, New York, where he has led projects that optimized manufacturing processes, increased yields, and reduced cleaning times and investigations. Polomene has extensive experience developing and validating manufacturing equipment, processes, and analytical methods across multiple drug products and presentations.
This document announces a professional development session on the pharmaceuticals dashboard for 2021. It will discuss topics like uncertainty in quality, the future of manufacturing and regulations, and competitiveness with trade barriers. The session aims to help professionals mature their skills and align with emerging expectations. It will use tutorials, discussions, examples and case studies. Participant assessment will be confidential. The session facilitators have extensive regulatory experience in Pakistan and international agencies. It will be held on December 19th in Karachi with a small group size.
Michael Buckley has over 25 years of experience in biotech developing monoclonal antibodies and antibody drug conjugates for oncology and immunology indications. He has held leadership roles at multiple biotech companies, directing preclinical and clinical development programs. Currently, he works as an independent consultant focusing on preclinical development and manufacturing of biologics from Phase I through commercial stage.
Focused Chemical/Microbiological technician highly effective at following USP methods and GMP practices with pharmaceutical and medical device experience.
Chemist accomplished in GC, HPLC, analytical and assay methods used on raw material and finished products to assure the quality and purity of products. Certified in Clinical Trials and Drug Development and worked side by side a chemical formulator R&D chemist for 3 years. Coordinated process validation procedures, stability program, chemical waste management system, calibration program, laboratory set up, ordering and SOP procedural writing.
Versed Microbiological surface and air quality testing, process validation, microbiological identification, trending, tracking, gram staining techniques and microbiological morphology. Certified in Pharmaceutical Microbiology.
1) The document summarizes a training session on Good Manufacturing Practices (GMP) of the 21st Century that focused on continuous manufacturing, data sciences, machine learning, and real time release.
2) It discusses that traditional quality practices are no longer sufficient and that transformation is needed to address increasing complexity and uncertainty in pharmaceutical manufacturing.
3) The document questions whether one-time process validation on 3 batches and a single bioavailability/bioequivalence study are sufficient to assure quality over a product's lifecycle.
PT SGS Indonesia is a premier provider of certification, testing, auditing, and training services in Indonesia. It operates environmental testing laboratories and provides services to sectors like mining, oil and gas, consumer products, and government. SGS offers audit, certification, and advisory services to help customers improve processes and attain sustainability. It has expertise across many disciplines relevant to environmental and health baseline studies. The document outlines SGS's proposed scope of work, which includes stakeholder engagement, auditing service providers, data validation, project management, and secure data storage. Contact information is provided for further discussion.
This document provides an introduction and overview of a training session on Good Manufacturing Practices (GMP) for the 21st century. It notes that the presentation will reflect the presenter's views and is not meant to represent any official policies. Examples of recent drug contamination and mix-ups are presented to illustrate the importance of GMP in ensuring consistent quality, preventing contamination and mix-ups. GMP is described as a set of regulatory methods to inspect manufacturing practices to protect the integrity and quality of products intended for human use and ensure they are consistently produced and controlled.
SMi Group's Prefilled Syringes East Coast 2018 conferenceDale Butler
This document summarizes a two-day conference on pre-filled syringes taking place in Boston on April 10-11, 2018. The conference will include two pre-conference workshops on human factors for connected drug delivery systems and design considerations for drug delivery outside the clinic. The main conference will focus on challenges and solutions for PFS manufacturing and processes, integrating quality by design principles, and trends toward increasing biologics and their implications for PFS. It will feature speakers from major pharmaceutical companies and include panel discussions on challenges of biologics delivery and PFS development.
This document summarizes a presentation on quality metrics and culture given at Habib University in Karachi. It discusses key quality metrics like lot acceptance rate, product complaint rate, and CAPA effectiveness. It also identifies attributes of a strong quality culture like leadership emphasis, message credibility, peer involvement, and employee ownership. Finally, it stresses that quality is everyone's responsibility and a mature quality system relies on systems thinking and a culture that prioritizes quality and continuous improvement.
SMi Group's Pharmaceutical Microbiology East Coast 2019 Dale Butler
This document provides information on the Pharmaceutical Microbiology East Coast conference taking place from April 10-11, 2019 in Boston, USA. It includes details on registration, chairpersons, key speakers and their topics. The conference will discuss challenges in pharmaceutical microbiology such as regulatory changes, environmental monitoring, rapid methods and sterility assurance. There will also be workshops on April 12th on mold contamination challenges and microbiological control using vapor phase hydrogen peroxide bio-decontamination. The event is aimed at professionals working in pharmaceutical microbiology.
Pharmaceutical Microbiology West Coast 2018Dale Butler
The document outlines the agenda for the 2nd Annual Pharmaceutical Microbiology West Coast conference on June 7-8, 2018 in San Diego. The conference will focus on key challenges and developments in pharmaceutical microbiology, with sessions on environmental monitoring, rapid methods, data integrity, aseptic processing, regulatory updates, and microbial identification. Speakers will present case studies and discuss issues like microbiological deviations, contamination control, disinfectant efficacy testing, and applying pharmaceutical microbiology technologies to other fields like human diagnostics. Workshops on June 6 will address risk-based environmental monitoring and microbial contamination control technologies.
The document advertises and provides an agenda for the 6th Annual Conference on Pharmaceutical Microbiology taking place January 17-19, 2017 in London. It will feature presentations and workshops on topics such as endotoxin testing, rapid microbial detection methods, environmental monitoring, and contamination control. Registration discounts are available before certain dates.
Biomanufacturing in China: Technologies and Facility DesignRita Barry
Join us as we DISCOVER, ANALYZE and LEARN the current state of the global biomanufacturing industry and the future growth potential and recent developments in Asia.
Some of the Key Highlights You Won’t Want to Miss Include
USA
Smart & Flexible Manufacturing Solutions in Multi-Product Facilities
Franz Walz, Executive Director Global Manufacturing, Science and Technology & Network Coordination, BOEHRINGER INGELHEIM
EUROPE
MAb Manufacturing Facilities for China & Automated Single-Use Processing to Bring Control & Flexibility to Manufacturing
Pauline Nicholson, Global Product Manager, Allegro Single-Use Systems, PALL
Niels Guldager, Senior Technology Partner, NNE PHRAMAPLAN
KOREA:
How to Bring Global Biopharmaceutical Capability through its Fully-Integrated Production Facilities?
Jeremy Caudill, Global VP Business Development, SAMSUNG BIOLOGICS
SINGAPORE
What do Investors Look for When Investing in Biologics Manufacturing?
Steven Lee, Global Head of Biologics Tech Operations & Managing Director, DR. REDDY'S LABORATORIES
INDIA
Developing a Multiproduct Facility for Biosimilars & Engineering & Biomanufacturing of Enzymes for Different Applications
Arvind Mishra, Global Head of Quality & Regulatory & Head of Strategic Business Unit, Biologicals,
CADILLA PHARMACEUTICALS
Ravindra Wagh, Vice President, ZYDUS BIOLOGICS
Rajeev Soni, Senior Manager, R&D, NOVOZYMES
HONGKONG
What are the Experiences & What is the Future for the Investors in the Biomanufacturing Space?
Ramesh Rajentheran, Head of Asian Healthcare Investment Banking, BARCLAYS
Jason Mann, Managing Director, FENEX CAPITAL MANAGEMENT
INDONESIA
Improving Quality Control & Maintenance of Global Biological Product Distribution
Galatia Chandra, Head of Sales & System, Global Operation, KALBE INTERNATIONAL PTE LTD
http://www.biomanufacturing-asia.com
SMi Group's Injectable Drug Delivery 2019 conferenceDale Butler
The document advertises the 2nd Annual Injectable Drug Delivery conference taking place May 14-16, 2019 in London. The conference will focus on innovations in injectable drug formulations and devices, with sessions on formulation development, device design, manufacturing, and regulatory issues. Speakers will discuss challenges and solutions for protein formulations, digital health technologies, long-acting injectables, pre-filled syringes and more. A pre-conference workshop on use-related risk analysis in product development will also be held. Attendees can register online or by phone.
SMi Presents the 5th Annual Conference on
Pharmaceutical Microbiology 20 - 21 JAN 2016
Pioneering new techniques for the prevention
detection and management of microorganisms
Taking place on the 20th and 21st January 2016, London UK, Pharmaceutical Microbiology event will provide essential insights in to the latest advancements in practice and technology, developments in regulation and harmonisation of international practice and evolving methods and the latest technology.
Join us as we explore key issues in data review and analysis, contamination control strategies, strategies for low endotoxin recovery and best practice in sterile and non-sterile manufacture. Gain an in-depth insight into endotoxin testing, validation and LER. Understand the threats posed by VBNCs and how to detect them.
For more information or to register for this conference please visit:
www.pharma-microbiology.com/lin
Book by 30th October and save £200!
Book by 30th November and save £100!
SMi Group's Injectable Drug Delivery 2018 conferenceDale Butler
This document provides information about two half-day pre-conference workshops on injectable drug delivery taking place on May 15, 2018 in London. Workshop A from 8:30-12:30 will focus on creating a human factors and usability engineering file in accordance with FDA and IEC62366-1 standards. Workshop B from 13:30-17:30 will examine wearable injectors and their ability to meet clinical needs while reducing healthcare costs. Both workshops aim to equip attendees with practical knowledge and strategies for developing safer and more user-friendly drug delivery devices and technologies.
Highly Potent Active Pharmaceutical Ingredients 2017Fateja Begum
This document advertises a conference on Highly Potent Active Pharmaceutical Ingredients to be held May 22-24, 2017 in London. The conference will address containment strategies, cross contamination risks, challenges in scaling up potent compounds, improving CMO strategies, and risk assessment. Two half-day workshops will also be held on preventing cross contamination and employee exposures, and on conducting risk assessments for HPAPIs using a HAZOP methodology. The conference aims to help participants balance safety, quality and cost-effectiveness when working with highly potent compounds.
SMi Group's Pharmaceutical Microbiology UK 2020Dale Butler
This document provides information on the upcoming Pharmaceutical Microbiology UK conference in January 2020. The conference will focus on contamination control, environmental monitoring, and current regulatory expectations. It will feature speakers from pharmaceutical companies and regulatory agencies who will discuss topics such as the impact of revisions to Annex 1, strategies for effective environmental monitoring programs, and novel methods for rapid microbial detection. A post-conference workshop day will include interactive sessions on developing risk-based cleaning approaches, designing environmental monitoring programs, and rapid microbiological methods and testing.
SMi Groups Highly Potent Active Pharmaceutical Ingredients (HPAPI)Dale Butler
This document provides an agenda for a conference on highly potent active pharmaceutical ingredients (HPAPIs) being held May 22-24, 2017 in London. The conference will address containment strategies, cross contamination risks, challenges in scaling up HPAPIs, improving contract manufacturing strategies, and risk assessment. Interactive half-day workshops on May 24 will focus on preventing cross contamination and employee exposures, and conducting a HAZOP risk assessment for HPAPIs. The event is aimed at sharing best practices for safely manufacturing these potent compounds.
This document summarizes an upcoming conference on superbugs and superdrugs taking place March 25-26, 2015 in London. The conference will focus on the latest developments in antibacterial therapies, funding, and partnerships to address antibiotic resistance. Over the two days, the conference will feature speakers from industry and academia discussing topics such as new business models for antibiotic development, clinical trials of new treatments, and partnerships between government and private organizations. Attendees can choose from two pre-conference workshops on designing antimicrobials for future needs and licensing an antibiotic. The conference is aimed at professionals involved in antibiotic research, development and related fields.
SMi Group's 3rd annual Biosimilars North America 2016Dale Butler
This document provides information about the "3rd Annual Conference on Biosimilars North America" event happening on November 15-17, 2016 in Iselin, New Jersey. It includes details about pre-conference workshops, the speaker lineup, and session topics which will address regulatory considerations, commercialization strategies, and technological developments for biosimilars in the US. Registration discounts are offered before June 30th and September 30th. The event is aimed at solving challenges and accelerating commercialization of biosimilars in North America.
This document provides information about a clinical quality and compliance masterclass conference taking place on June 16th and 17th, 2016 in Vienna. The conference will focus on managing clinical quality for greater compliance, effectiveness, and audit readiness. Over the two days, there will be keynote speakers from major pharmaceutical companies, case studies, and workshops on topics such as on-site quality improvements, inspection readiness, quality risk management, and third-party oversight. Attendees will include quality assurance professionals from pharmaceutical and biotech companies as well as CROs.
This document provides information about an upcoming conference on immunogenicity taking place June 13-14, 2016 in London. It lists the schedule, speakers, and topics to be covered over the two days. The conference will explore approaches to standardizing immunogenicity assays, unwanted immunogenicity, integrating immunogenicity risk data to predict clinical outcomes, and other topics related to assessing and reducing the immunogenicity of biotherapeutics. Registration discounts are available by March 31st or April 29th. The conference is aimed at accelerating the commercialization of next generation biotherapeutics by adopting advanced immunogenicity assessments.
This document provides information about an upcoming conference on immunogenicity to be held June 13-14, 2016 in London. It includes an overview of the conference sessions and speakers. The sessions will cover topics such as approaches to standardizing drug level and anti-drug antibody assays, unwanted immunogenicity, integrating immunogenicity risk data, immunogenicity of biologics and biosimilars, and the role of aggregation in immunogenicity. There will also be two half-day post-conference workshops on June 15 on standardizing assays for biotherapeutics and unwanted immunogenicity from the bench to the bedside. The conference is aimed at accelerating development and approval of next generation biotherapeutics by adopting
SMi’s 3rd annual conference
Immunogenicity
13th and 14th June 2016, Holiday In Kensington Forum, London, UK.
Immunogenicity of an antigen is frequently encountered in the context of vaccine development, an area of intense interest currently due to the emergence or re-emergence of infectious pathogens with the potential for worldwide spread. With the global vaccine market expected to reach $84.44 billion by 2022, now is the time engage with industry experts to addresses the real challenges with immunogenicity including assay assessment, the role of aggregation, the introduction of nanobodies and many more!
For further information or to register please visit the event website www.immuno.co.uk or contact Matthew Apps on +44 (0) 207 827 6093 or mapps@smi-online.co.uk
SMi is proud to present the 2017 19th annual Superbugs & Superdrugs conference, taking place on 20th and 21st March in Central London.
Expanding horizons on the growing threat of anti-microbial resistance for almost two decades, the flagship show in the global Superbugs portfolio of events will once again play host to an international audience of scientific leaders, funding bodies and drug discovery specialists, providing a focal point to push industry collaboration through updates on clinical advancements and investment opportunities.
This document announces a conference on risk-based monitoring in clinical trials taking place on November 5-6, 2015 in Philadelphia. The conference will discuss how risk-based monitoring involves more than just monitoring and focuses on managing risk throughout the entire clinical trial process from protocol design through analysis. Speakers will address topics like how FDA inspections have adapted to risk-based monitoring, the impact of risk-based monitoring on the role of monitors, integrating technology like eSource data capture to enable risk-based trials, and how smaller organizations can implement risk-based monitoring.
Similar to SMi Group's Pharmaceutical Microbiology East Coast 2017 conference (20)
SMi Group's Pre-filled Syringes West Coast 2020 conferenceDale Butler
This document provides an agenda for the 5th annual Pre-Filled Syringes West Coast conference taking place June 15-17, 2020 in San Diego, CA. The conference will focus on innovations in device design and technology, advances in human factors engineering, combination product regulatory insights, and design controls and risk management. It will feature presentations from industry leaders at companies like Genentech and AstraZeneca as well as regulators from the FDA. There will also be two post-conference workshops on June 17th focusing on navigating FDA requirements for connected devices and digital health, and post-market safety reporting for combination products.
SMi Group's Military Robotics and Autonomous Systems USA 2020 conferenceDale Butler
This document advertises the Military Robotics and Autonomous Systems USA conference happening on June 22-23, 2020 in Arlington, Virginia. Attendees can save $400 by registering by February 28, $200 by registering by March 31, and $100 by registering by April 30. The conference will discuss topics like US Army robotics programs, Australian Army robotics development, unmanned vehicle programs, robotics supporting warfighters' mobility and sustainability, and integrating robotics into ground formations. Speakers will include representatives from the US and Australian militaries as well as academics working on relevant research.
SMi Group's Future Soldier Technology USA 2020 conferenceDale Butler
The document announces the 2nd Annual Future Soldier Technology USA conference on June 8-10, 2020 in Arlington, Virginia. The conference will focus on modernizing equipment for dismounted soldiers and marines, and feature speakers from the US and other militaries involved in soldier technology programs. Over 150 attendees are expected to discuss initiatives like NGSW-AR/R/FC, ISSP, and manned-unmanned teaming to enhance soldier lethality, mobility, and situational awareness.
SMi Group's Military Space USA 2020 conferenceDale Butler
This document provides an agenda for the 2nd Annual Military Space USA Conference supporting the US military space enterprise. The conference will include presentations from senior leaders in the US Space Force, Air Force, and other allied militaries on topics such as space acquisition reform through SMC 2.0, training the future space warfighting force, and leveraging disruptive commercial space technologies. A separate focus day will explore experimental smallsat capabilities, export controls for space technologies, advanced propulsion concepts, using LEO mega-constellations for bandwidth, in-orbit manufacturing, and accelerating commercial innovation. The event aims to connect disruptors and innovators with government to integrate new technologies rapidly into military space operations.
This document summarizes a conference focused on helicopter technology for Central and Eastern Europe being held in Budapest, Hungary on May 20-21, 2020. It will feature keynote speeches from military leaders from Hungary, Slovakia, Romania, Germany, and Croatia on developments and modernization efforts of their national helicopter fleets. Technical experts from the US, UK, Netherlands, and Czech Republic will also present. Sessions will discuss regional cooperation and interoperability, training standards, and enhancing capabilities like search and rescue. The goal is focused discussion on challenges facing helicopter program managers and informal networking for participants.
This document provides information about an upcoming conference on future armoured vehicles in Central and Eastern Europe in 2020. It outlines early registration discounts that decrease over time, as well as special rates for military and government representatives. The document details benefits of attending the conference, including hearing updates from armed forces in the region. It lists speakers from various countries who will discuss topics like armoured vehicle programmes, enhancing capabilities, and ensuring interoperability. The agenda outlines presentations over two days covering issues like future infantry fighting vehicles, enhancing mechanization capabilities, and modernizing ground platforms. The document promotes sponsorship opportunities at the event.
SMi Group's Unmanned Maritime Systems 2020 conferenceDale Butler
This document provides information about the 4th Annual Unmanned Maritime Systems conference taking place on April 13-14, 2020 in London. It discusses key reasons to attend like hearing from naval officers on integrating unmanned assets and learning about updates on unmanned platforms, anti-submarine warfare, mine countermeasures, and technological innovation. The agenda outlines presentations and speakers from military organizations like the Royal Navy, US Navy, Spanish Navy, and NATO who will discuss topics like developing unmanned systems, accelerating unmanned technologies, and using unmanned systems for mine countermeasure operations.
SMi Group's Military PNT 2020 conferenceDale Butler
The document summarizes the agenda for the "Military PNT 2020" conference to be held on May 18-19 in London. The event highlights include briefings from the US DoD on GPS and NTS-3 programs, understanding requirements for operating in degraded PNT environments, and engaging with industry and military leaders. The agenda covers topics such as UK PNT strategies, warfighter PNT considerations, legal perspectives on PNT resilience, and GNSS interference case studies. Keynote speakers include representatives from the US Air Force, Lockheed Martin, UK MoD, DGA, NPL, and BHO Legal.
This document provides an agenda for the Defence Aviation Safety conference taking place on April 23-24, 2020 in London. The agenda includes keynote presentations and panels on topics related to ensuring safety across defence aviation programs and platforms. Speakers will represent organisations such as the UK Ministry of Defence, US Air Force, German Military Aviation Authority, and NATO. Presentation topics will cover safety priorities, certification processes, training, accident investigation and lessons learned. A closing panel on day two will discuss the challenges of ensuring military aviation safety and cyber resilience.
SMi Group's Pre-filled Syringes East Coast 2020 Dale Butler
This document announces an interactive workshop on combination product development taking place on April 29th, 2020 in Boston, USA. The workshop will consist of three sessions focused on key topics in combination product development: combination product development strategies, drug delivery device testing solutions, and human factors validation studies. Speakers will include experts from major pharmaceutical companies such as AstraZeneca, Eli Lilly, Biogen, and regulatory agencies. The workshop aims to provide attendees insights and strategies for navigating challenges in combination product development from concept to approval.
SMi Group's Air Mission Planning and Support 2020Dale Butler
The document announces an upcoming conference on "Maximising Air Power through the Development and Integration of Innovative Support Systems" to be held in London on April 21-22, 2020. The conference will examine developments in air mission planning and focus on data management, fifth generation integration, and multi-domain command and control. It will feature expert military speakers from countries like the UK, US, Canada, France, Hungary, and Belgium representing air forces, NATO, and DARPA to discuss challenges and solutions.
SMi Group's Military Robotics and Autonomous Systems 2020 Dale Butler
This document provides information about the 3rd Annual Military Robotics and Autonomous Systems conference taking place on April 1-2, 2020 in London. It outlines the key topics to be discussed including UK and international perspectives on robotic and autonomous systems programs and strategies. Speakers will address topics such as unmanned ground vehicle development, autonomy for military robotic systems, and manned-unmanned teaming. The conference will explore delivering quality robotic systems to enhance operational effectiveness and discuss technology demonstrations.
This document advertises the 6th Annual Future Soldier Technology conference taking place March 9-11, 2020 in London. The conference will focus on dismounted soldier and marine technology, discussing key areas like dismounted capability. Military, procurement, and research experts from around the world will present on their soldier programs, challenges, and successes. Attendees can learn the latest developments, network with key speakers and decision makers, and gather intelligence to inform their projects. The conference aims to allow information sharing on equipping soldiers to maintain an advantage against evolving adversaries.
This document provides information about the 5th Annual Defence Logistics Central & Eastern Europe conference taking place on March 3-4, 2020 in Budapest, Hungary. The summary includes:
- The conference will bring together senior military, government, and industry personnel from Central and Eastern Europe to discuss developments in defence logistics and increase cooperation in the region.
- Over the two days, there will be keynote briefings and panels on topics like modernizing logistics structures, interoperability, operational capabilities of country logistics divisions, and industry roles. Speakers will represent militaries like Hungary, Czech Republic, Poland, and industry sponsors.
- Attendees can benefit from networking opportunities and learning about log
The document announces Space Week, consisting of the Small Satellites Conference from April 27-28 and the Military Space Situational Awareness Conference from April 29-30 in London. It provides details on the conferences, including chairpersons, speakers from various space agencies, companies, and militaries, and topics to be discussed such as small satellites, space insurance, disruptive approaches to space, space data, and military space situational awareness. The document aims to invite colleagues to participate in Space Week to explore developments in small satellites and how to track and manage space assets.
SMi Group's Superbugs and Superdrugs 2020 conferenceDale Butler
This document provides information about the Superbugs & Superdrugs conference on March 30-31, 2020 in London. The conference will focus on non-traditional approaches to fighting antimicrobial resistance and will feature speakers from companies and organizations working on alternatives to antibiotics, including those developing antibacterial proteins, agents that neutralize bacterial virulence, direct lytic agents, and immunomodulatory therapies. It provides details on the agenda, speakers, workshops, registration and sponsorship opportunities.
SMi Group's AI in Drug Discovery 2020 conferenceDale Butler
This document provides information about an upcoming conference on AI in Drug Discovery taking place from March 16-17, 2020 in London, UK. It includes details about the program, speakers, registration fees and deadlines. The conference will explore how machine learning and AI are being applied across the drug discovery process, from compound design and virtual screening to toxicity prediction. There will be case studies presented from major pharmaceutical companies on their experience integrating AI. The document also advertises sponsorship opportunities for the event.
The document announces a conference on exploring the small satellite revolution and its impact on future space. It will be held on April 27-28, 2020 in London, UK and include a half-day post-conference workshop on April 29. The conference will discuss topics such as disruptive approaches to space, small satellite applications, space data and networking, insurance, and market trends and opportunities. It will feature expert speakers from organizations such as NASA, Surrey Satellite Technology, the Israeli Space Agency, US Air Force, and more. Attendees can learn about key small satellite programs and how these systems are transforming capabilities.
How to Make a Field Mandatory in Odoo 17Celine George
In Odoo, making a field required can be done through both Python code and XML views. When you set the required attribute to True in Python code, it makes the field required across all views where it's used. Conversely, when you set the required attribute in XML views, it makes the field required only in the context of that particular view.
বাংলাদেশের অর্থনৈতিক সমীক্ষা ২০২৪ [Bangladesh Economic Review 2024 Bangla.pdf] কম্পিউটার , ট্যাব ও স্মার্ট ফোন ভার্সন সহ সম্পূর্ণ বাংলা ই-বুক বা pdf বই " সুচিপত্র ...বুকমার্ক মেনু 🔖 ও হাইপার লিংক মেনু 📝👆 যুক্ত ..
আমাদের সবার জন্য খুব খুব গুরুত্বপূর্ণ একটি বই ..বিসিএস, ব্যাংক, ইউনিভার্সিটি ভর্তি ও যে কোন প্রতিযোগিতা মূলক পরীক্ষার জন্য এর খুব ইম্পরট্যান্ট একটি বিষয় ...তাছাড়া বাংলাদেশের সাম্প্রতিক যে কোন ডাটা বা তথ্য এই বইতে পাবেন ...
তাই একজন নাগরিক হিসাবে এই তথ্য গুলো আপনার জানা প্রয়োজন ...।
বিসিএস ও ব্যাংক এর লিখিত পরীক্ষা ...+এছাড়া মাধ্যমিক ও উচ্চমাধ্যমিকের স্টুডেন্টদের জন্য অনেক কাজে আসবে ...
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
How to Build a Module in Odoo 17 Using the Scaffold MethodCeline George
Odoo provides an option for creating a module by using a single line command. By using this command the user can make a whole structure of a module. It is very easy for a beginner to make a module. There is no need to make each file manually. This slide will show how to create a module using the scaffold method.
The simplified electron and muon model, Oscillating Spacetime: The Foundation...RitikBhardwaj56
Discover the Simplified Electron and Muon Model: A New Wave-Based Approach to Understanding Particles delves into a groundbreaking theory that presents electrons and muons as rotating soliton waves within oscillating spacetime. Geared towards students, researchers, and science buffs, this book breaks down complex ideas into simple explanations. It covers topics such as electron waves, temporal dynamics, and the implications of this model on particle physics. With clear illustrations and easy-to-follow explanations, readers will gain a new outlook on the universe's fundamental nature.
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
हिंदी वर्णमाला पीपीटी, hindi alphabet PPT presentation, hindi varnamala PPT, Hindi Varnamala pdf, हिंदी स्वर, हिंदी व्यंजन, sikhiye hindi varnmala, dr. mulla adam ali, hindi language and literature, hindi alphabet with drawing, hindi alphabet pdf, hindi varnamala for childrens, hindi language, hindi varnamala practice for kids, https://www.drmullaadamali.com
SMi Group's Pharmaceutical Microbiology East Coast 2017 conference
1. B: Contamination Control
in Cleanrooms
13.30 - 17.30
Workshop Leader:
Jim Polarine, Senior Technical Service Manager,
STERIS Corporation
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 15th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
www.microbiologyeastcoast.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
@SMIPHARM
#SMiMicroEast
A: Navigating the requirements of a modern QC
Microbiology Laboratory
08.30 - 12.30
Workshop Leaders:
Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical Microbiologist,
Quality Executive Partners, Inc. and Robert Ferer, Consulting Partner / Strategic
Practice Lead, Quality Executive Partners, Inc.
HIGHLIGHTS IN 2017:
• Learn more about Rapid Microbial Methods, Microbe
Interaction and Stability Testing by implementing a Microbial
Control Strategy to avoid failure
• Listen to in depth presentations about Environmental
Monitoring, its challenges of avoiding risks and how to monitor
and control microbial containment
• Expand your knowledge on Contamination Control and how to
identify and improve this by learning from various case studies
presenting different solutions
• Gather expert insight on different methods for Bacterial
Endotoxin Testing, including a case study on Low Endotoxins
Recovery strategies
SMi present the 8th in its series...
Pharmaceutical
Microbiology East Coast
Discussing best practises for rapid microbial and sterility
testing and tackling the challenges of contamination control
CONFERENCE:
13TH - 14TH
WORKSHOPS: 15TH
NOV
2017
CHAIR FOR 2017:
• Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
KEY SPEAKERS INCLUDE:
• Joseph Chen, Executive Director, CMC Quality Control,
Ultragenyx Pharmaceutical
• Geeta Singh, Pilot Plant Technical Specialist III, Genentech
• Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline
• Tony van Hoose, Director, Sterile Technologies Expertise, Sanofi
• Frederic Ayers, Consultant Scientist, Sterility Assurance, Eli Lilly
• David Huang, Chief Medical Officer, Motif Bio
• Andrew Bartko, Research Leader, Battelle Memorial Institute
Sponsored by
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
BOOK BY 30TH JUNE 2017 AND SAVE $300
BOOK BY 29TH SEPTEMBER 2017 AND SAVE $100
2. Register online at www.microbiologyeastcoast.com
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking
opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join
the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
For over 30 years, Charles River has helped customers bring products to market safely and efficiently with
revolutionary technologies and exceptional services that have changed the way we conduct microbial
quality control. Continuing with a passion to innovate and respond to customers’ needs, our Microbial Solutions
group has purposefully expanded its global portfolio to include the leading rapid microbial detection systems
of Celsis®. Joining the trusted brands of Endosafe® endotoxin testing and Accugenix® microbial identification,
Celsis® creates a powerful trio of micro QC solutions, the most comprehensive offering available from any
single provider. www.criver.com/microbialsolutions
Sponsored by
08.30 Registration & Coffee
09.00 Chair’s Opening Remarks
Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
MICROBIAL CONTROL STRATEGIES AND QUALITY METHODS
OPENING KEYNOTE ADDRESS:
09.10 The Role of Microbiology in Pharmaceutical Stability Programs
• Stability Study Requirements: RD versus Marketed Products
• What Microbial Tests are Stability Test Parameters
• Stability Testing Appropriate for Different Dosage Forms
• Managing the Stability Commitments in your Regulatory Filings
• Investigating Stability Test Failures
Tony Cundell, Principal Consultant,
Microbiological Consulting, LLC
09.50 How does a Non-GMP Biopharmaceutical Pilot Facility deliver
high run rate with high success?
• CHO and E. coli process development overview
• Provide an overview of the premier Pilot Plant facility in Biotech
USA that executes more than 1500 CHO and E. coli experiments
per year to support Genentech’s pipeline
• Discuss microbial contamination case studies and the lessons
learned
• Discuss how critical it is to maintain good health of the non-GMP
facility to achieve high success rate
Geeta Singh, Pilot Plant Technical Specialist III, Genentech
10.30 Morning Coffee Networking Break
11.00 Amplified ATP Bioluminescence Rapid Sterility Test Validation
Utilizing a Defined Method for Stressing Microorganisms
• Provides an efficient, and reproducible method for generating
log reductions in microbial cultures
• Comparative data / illustrations shall be presented to
demonstrate stressing procedural efficacy
• The impact of stressed organisms on Time to Detect,
and Limit of detection shall be demonstrated
Shawn Sweeney, Senior Process
Development Manager, Charles River
11.40 Deciphering the Host-Microbe Interaction
• The microbiome is implicated in several chronic disorders
• The metabolites produced by the microbes are chemical
messengers interacting with host receptors
• Studying this interaction will have important knowledge building
around disease pathologies
Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline
12.20 Networking Lunch
ENVIRONMENTAL MONITORING TO AVOID POTENTIAL RISKS
13.30 Benefits of Real-time Monitoring of Airborne Viable
Microorganisms
• Bio-fluorescent active air particle counting of airborne viable
microorganisms
• Continuous real-time Environmental Monitoring of Classified
Environments
• Risk mitigation
James Hauschild, Principal Scientist, Johnson Johnson
14.10 Current Expectations for a Complete Environmental Monitoring
Program
• Increasing expectations for non-sterile manufacturers
• Types of functions that should be included in the program -
besides monitoring
• What is required in these functions
• How to put the system together
Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
14.50 Microbial Environmental Control Assessment using Microbial
Recovery Trends
• Microbial Recovery rate trend analysis is stated by USP 1116
to evaluate microbial control levels in aseptic process areas
• Microbial Recovery rates trend analysis has demonstrated being
an excellent toll to determine the efficiency of microbial control
corrective actions
• The purpose of this presentation is to review the results of our
assessment in classified areas
Angel Salaman, Principal Process Scientist, Janssen Biotech
15.30 Afternoon Tea Networking Break
BACTERIAL ENDOTOXIN TESTING AND LER STRATEGIES
16.00 Quality Control Strategy on Low Endotoxins Recovery (LER)
• Discuss common formulation ingredients in biologics cause LER
• Risk assessment approach in mitigating LER impact on product
quality
• Case study on analytical solution to LER and alternatives
Joseph Chen, Executive Director, CMC Quality Control,
Ultragenyx Pharmaceutical
16.40 Method Development
• How to determine the Maximum Valid Dilution (MVD)
• Endotoxin inhibition / enhancement
• How to determine endotoxin limits on raw materials and
excipients
Josephine Chan, Microbiology Supervisor, Teligent Pharma Inc.
17.20 Chair’s Closing Remarks and Close of Day One
Pharmaceutical Microbiology East Coast
Day One | Monday 13th November 2017 www.microbiologyeastcoast.com
3. Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
MARKETING OPPORTUNITIES
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Kyra Williams, SMi Marketing on +44 (0) 207 827 6012 or email: kwilliams@smi-online.co.uk
08.30 Registration Coffee
09.00 Chair’s Opening Remarks
Jeanne Moldenhauer, Vice President,
Excellent Pharma Consulting
CONTAMINATION CONTROL AND STERILITY ASSURANCE
OPENING ADDRESS:
09.10 Implementation of a Risk Based Model for Cleaning and
Disinfection
•Development of a risk based model for cleaning and
disinfection
•Using a risk model for room recovery following an adverse event
•Implementation strategy for introducing a risk based cleaning
and disinfection regimen
Steve Walton, Technical Manager, Sanofi Pasteur
09.50 Contamination Challenges
•Combatting Mold: Introducing a simple method to eliminate
and prevent mold anywhere
•Discussing fast and simple methods to eliminate and prevent
biofilm
•Easy ways to eliminate spores quickly and safely for your
equipment/surfaces
Brian Hubka, CEO, BGH International
10.30 Morning Coffee Networking Break
11.00 Training of Media Fill Inspection Operators
•Training Program Overview
•Creation of Positive Containers
•Test/Inspection Conditions
•Certification of Operators
•Recertification/Retraining – Frequency and Basis
Tony van Hoose, Director, Sterile Technologies Expertise, Sanofi
KEYNOTE ADDRESS
11.40 Implementation of a Global Electronic Intervention Logging System
Sterility is one of the most critical quality attributes that all
parenteral products must possess; yet, it is one of the most difficult
to consistently and convincingly demonstrate. This presentation
discusses an integrated, cross-functional strategy implemented
within Eli Lilly and Company’s parenteral manufacturing network.
This strategy identifies, assesses, documents, and evaluates the
single largest source of microbial hazard within aseptic filling areas
– aseptic personnel.
•This presentation will describe an Aseptic Manipulation and
Intervention Program, which establishes the requirements for
how aseptic interventions and manipulations are identified,
assessed, and executed
•This presentation will describe the Intervention Logging System
which allows for real-time electronic documentation and
approval of non-coded interventions performed on aseptic
filling lines
•This presentation will describe the use of RFID for
documentation of Electronic Signature for activities within the
aseptic areas
Collectively, these provide quantifiable information that helps
mitigate the risk of personnel-induced microbial hazard of
products filled in aseptic environments.
The attendees will understand the importance of developing
a robust intervention strategy with appropriate definitions of
activities. Additionally, identifying, assessing and mitigating all
aseptic interventions and manipulations allow for consistent
evaluation of filler performance across a platform.
Frederic Ayers, Consultant Scientist, Sterility Assurance, Eli Lilly
12.20 Networking Lunch
RAPID MICROBIAL DETECTION AND DESIGNED THERAPIES
13.30 Rapid microbial-detection methods
•The benefits, applications, pitfalls and challenges involved
•Time to result benefits to manufacturing economics
•Enhanced quality control impact on manufacturing risk
•Overcoming the hurdles of new technology validation
Andrew Bartko, Research Leader, Battelle Memorial Institute
14.10 Designed microbiome therapies targeting the microbes and beyond
•The gut microbiome plays an essential role in disease regulation
and efficacy of therapies. Altered microbial communities, also
termed dysbiosis, has been observed in many intestinal and
extra-intestinal inflammatory disorders
•There is not yet a clear understanding whether dysbiosis is a
cause or a consequence of the diseases. Microbial therapies
which only target the dysbiosis have shown limited success
•A healthy gut microbiota exists in an equilibrium with the gut
barrier and the immune system
•The importance of multiple-target drug cocktails comprising
commensal bacteria will be discussed. The bacterial library,
screening technologies and design of potential and affordable
drugs will be presented with particular focus on successful
products that treat Irritable Bowel Syndrome (IBS) and
Clostridium Difficile Infection
Shahram Lavasani, Founder CEO, ImmuneBiotech AB
14.50 Afternoon Tea Networking Break
15.20 Iclaprim, a novel diaminopyrimidine, for the treatment of serious
Gram-positive infections
•Iclaprim addresses an unmet medical need in hospitalized
patients with serious and life threatening infections including MRSA
•Iclaprim possesses a differentiated product profile in target
patient populations
•Iclaprim provides a near-term product opportunity
David Huang, Chief Medical Officer, Motif BioSciences
16.00 Biological Treatment of Emerging Contaminants Prevalent in
Pharmaceutical Effluents
•Pharmaceutical wastewater commonly consists of
contaminants of emerging concerns, such as antibiotics,
estrogens, and 1,4-dioxane
•Bacteria that can degrade or biotransform these xenobiotic
compounds are more widespread than previously recognized
•Modern culture-independent biotechnologies facilitate the
identification of microorganisms with unique biotransformation
capabilities
•Biologically active filtration system is one of top effective and
economical techniques for removal of commingled emerging
contaminants in pharmaceutical waste streams
Mengyan Li, Assistant Professor, New Jersey Institute of Technology
16.40 Chair’s Closing Remarks and Close of Day Two
Pharmaceutical Microbiology East Coast
www.microbiologyeastcoast.com Day Two | Tuesday 14th November 2017
Supported byOfficial Media Partners:
4. A: Navigating the requirements of a
modern QC Microbiology Laboratory
Overview of the workshop:
This workshop will introduce ideas for blending traditional
microbiology with the cutting edge methodologies that are
available to the industry, both inside the laboratory and on the
manufacturing floor for routine monitoring programs. It will also
provide practical approaches for common laboratory issues
surrounding implementation of alternative technologies, data
integrity and analyst training.
Why you should attend:
This workshop is designed to inspire and motivate the attendee
for understanding the evolution of microbiological methods in
pharmaceutical manufacturing, and basic expectations for
building quality into the product.
Programme
08.30 Registration Coffee
09.00 Opening Remarks
09.10 Session 1 - The Modern Microbiology Lab
• Learn about current trends in QC Microbiology
• Solutions for when to upgrade technology in your lab
09.50 Session 2 - Real Time Release Testing
• Learn about options available for monitoring water
products in real time
• Discuss the creation and application of new
excursion criteria
10.30 Morning Coffee
11.00 Session 3 - Data Integrity in a Digital Lab
• Application of data integrity for conventional
alternative lab methods
• Practical approaches safeguards against
common mistakes
11.40 Session 4 - The iMicrobiologist
• Blending old new technologies in the QC
Microbiology lab
• Understanding, hiring training the new
generation of talent
12.20 Closing Remarks
12.30 Close of Workshop
About the workshop leaders:
Vanessa Vasadi-Figueroa, Pharmaceutical Microbiologist
and Consulting Partner, has more than 12 years combined
experience in Pharmaceutical, Biotechnology and Medical
Device industries. Mrs. Figueroa has expertise in sterility
assurance, environmental and utilities monitoring programs
and quality control laboratory management. Her consulting
experiences have spanned both domestic and international
large pharmaceutical companies, applying both US and
global regulatory standards of quality. Mrs. Figueroa has a
Bachelor’s degree in Molecular Biology from State University of
New York at New Paltz, and a Master’s degree in Molecular
Biology and Microbiology from San Jose State University. She
is an active and contributing member of several professional
organizations, such as the Parenteral Drug Association,
American Society of Microbiology and Association for Women
in Science.
Robert Ferer, Engineering Chemist and Consulting Partner
with more than 28 year’s direct industry experience including
the design, build, start-up, and management of facilities,
specializing in aseptic manufacturing. Mr. Ferer’s experience
covers all aspects of pharmaceutical operations from receipt
of raw materials through inspection, final packaging, and
shipping of finished products. As a consultant, he is frequently
contracted to manage large-scale projects and provide
high-level strategy and goal definition to clients. This includes
due diligence, facility audits, compliance, and regulatory
guidance for North America as well as EU markets. Mr. Ferer
has a Bachelors degree in Engineering Chemistry from the
State University of New York at Stony Brook and is a contributing
member of both the International Society of Pharmaceutical
Engineers and the Parenteral Drug Association.
About the company:
At Quality Executive Partners (QxP), our mission is to bring
bold revolution to quality consulting. We are fueled by the
passion for doing what is right and being the much needed
disruptive innovation! The QxP team is comprised of executives
with extensive track records delivering successful outcomes
in situations of intense regulatory scrutiny. Our executives
have substantial experience interacting and negotiating
with FDA and other global regulatory agencies. We take a
pragmatic, strategic view of internal processes, quality system
development, and implementation of key matters.
Workshop Leaders:
Vanessa Vasadi-Figueroa, Consulting Partner / Pharmaceutical
Microbiologist, Quality Executive Partners, Inc.
Robert Ferer, Consulting Partner / Strategic Practice Lead,
Quality Executive Partners, Inc.
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 15th November 2017
08.30 – 12.30
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
5. B: Contamination Control
in Cleanrooms
Overview of the workshop:
Staying ahead of the curve with Contamination Control
requires an understanding and an anticipation of the
constantly changing microbial climate of the pharmaceutical
manufacturing process. Knowing the characteristics of the
environments in that process provides the benefit of allowing
us to predict and solve potential future microbial control issues.
This session will discuss pathways to use the data obtained from
environmental monitoring to provide proactive and practical
solutions for comprehending and managing everyday
pharmaceutical microbiology challenges. This workshop will
cover case studies on human flora and spore contamination in
cleanroom operations. Solutions will be discussed to proactively
present future contamination issues.
The workshop will cover the most common causes of
contamination: operators, items brought into the cleanroom,
and degradation of the cleanroom over time. Case studies
in operator borne contamination will be discussed as well as
preventative long term solutions. Specific examples of aerobic
and anaerobic vegetative bacteria will be highlighted and
analyzed. Items brought into cleanrooms that can harbor
fungal and bacterial spores will be discussed as well as specific
case studies highlighting examples where sources were items
brought into the cleanroom or in some cases other common
causes. Fungal and bacterial spore structures as well as efficacy
testing and specific test conditions will be covered. Solutions
will be presented to prevent efficacy testing failures due to test
method, recovery, and coupon porosity issues. Targeted long
term solutions will be discussed regarding the spore case studies
in a concerted effort to limit reoccurrences.
The overall objective and scope of this workshop will be to
discuss specific cases studies that have occurred in my years of
experience in the industry. Specific long term solutions will be
conveyed to prevent reoccurrences and yield higher levels of
control in the cleanroom operations. The concepts of cleaning
and disinfection, application frequency, disinfectant rotation,
and rinsing and residue removal strategies will be covered in
complete detail as well.
Why should you attend this workshop:
This industry workshop will give attendees valuable insight into
the world of contamination control and troubleshooting fungal
and bacterial spore excursions in cleanrooms. Attendees will
gain new insight into common causes of CAPA investigations
which will cut down on time that is invested finding potential
causes for contamination which can cost an organization 50K
per investigation.
Programme
13.30 Registration Coffee
14.00 Opening Remarks and Introductions
14.10 Session 1 - Common Sources of Contamination:
Case Studies
14.50 Session 2 - A Risk Based Cleaning and
Disinfection Program
15.30 Afternoon Tea
16.00 Session 3 - Key Elements of a Successful
Disinfectant Validation Program
16.40 Session 4 - Bringing the Cleanroom Online After
a Worst-Case Event
17.20 Closing Remarks
17.30 Close of Workshop
About the workshop leader:
Mr. Polarine is a senior technical service manager at STERIS
Corporation. He has been with STERIS Corporation for seventeen
years. His current technical focus is microbial control in
cleanrooms and other critical environments. He has lectured in
North America, Europe, Middle East, Asia, and Latin America on
issues related to cleaning and disinfection in cleanrooms. Mr.
Polarine is a frequent industry speaker and published several
PDA book chapters and articles related to cleaning and
disinfection and contamination control. He is active as co-
chair on the PDA’s microbial investigations task force. He was
a co-author on PDA’s Technical Report #70 on Cleaning and
Disinfection. Mr. Polarine graduated from the University of Illinois
withaMasterofArtsinBiology. Hepreviouslyworkedasaclinical
research coordinator with the Department of Veterans Affairs in
St. Louis, MO and as a biology and microbiology instructor at the
University of Illinois. His main hobby is storm chasing and is very
active in tornado research and tornado safety.
About the organisation:
STERIS is a global leader in infection prevention, contamination
control, surgical and critical care technologies, and more.
STERIS is the world’s pre-eminent infection prevention,
decontamination, and surgical and critical care company.
Workshop Leader:
Jim Polarine, Senior Technical Service Manager,
STERIS Corporation
HALF-DAY POST-CONFERENCE WORKSHOP
Wednesday 15th November 2017
13.30 – 17.30
Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
6. PHARMACEUTICAL MICROBIOLOGY EAST COAST
Conference: Monday 13th Tuesday 14th November 2017, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Workshops: Wednesday 15th November 2017, New Jersey, USA
4 WAYS TO REGISTER
www.microbiologyeastcoast.com
FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd,
Ground First Floor, 1 Westminster Bridge Road London, SE1 7XW, UK
Please complete fully and clearly in capital letters. Please photocopy for additional delegates.
Title: Forename:
Surname:
Job Title:
Department/Division:
Company/Organisation:
Email:
Company VAT Number:
Address:
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Mobile:
Switchboard:
Signature: Date:
I agree to be bound by SMi’s Terms and Conditions of Booking.
ACCOUNTS DEPT
Title: Forename:
Surname:
Email:
Address (if different from above):
Town/City:
Post/Zip Code: Country:
Direct Tel: Direct Fax:
Payment: If payment is not made at the time of booking, then an invoice will be issued and must
be paid immediately and prior to the start of the event. If payment has not been received then
credit card details will be requested and payment taken before entry to the event. Bookings within
7 days of event require payment on booking. Access to the Document Portal will not be given until
payment has been received.
Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, another
delegate to take your place at any time prior to the start of the event. Two or more delegates may
not ‘share’ a place at an event. Please make separate bookings for each delegate.
Cancellation: If you wish to cancel your attendance at an event and you are unable to send
a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge,
providing that cancellation is made in writing and received at least 28 days prior to the start of the
event. Regretfully cancellation after this time cannot be accepted. We will however provide the
conferencesdocumentationviatheDocumentPortaltoanydelegatewhohaspaidbutisunable
to attend for any reason. Due to the interactive nature of the Briefings we are not normally able
to provide documentation in these circumstances. We cannot accept cancellations of orders
placed for Documentation or the Document Portal as these are reproduced specifically to order.
If we have to cancel the event for any reason, then we will make a full refund immediately, but
disclaim any further liability.
Alterations: It may become necessary for us to make alterations to the content, speakers, timing,
venue or date of the event compared to the advertised programme.
Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection
Act 1998 and we may use this to contact you by telephone, fax, post or email to tell you about
other products and services. Unless you tick here □ we may also share your data with third parties
offeringcomplementaryproductsorservices.Ifyouhaveanyqueriesorwanttoupdateanyofthe
data that we hold then please contact our Database Manager databasemanager@smi-online.
co.uk or visit our website www.smi-online.co.uk/updates quoting the URN as detailed above your
address on the attached letter.
Payment must be made to SMi Group Ltd, and received before the event, by one of the
following methods quoting reference P-261 and the delegate’s name. Bookings made within
7 days of the event require payment on booking, methods of payment:
□ UK BACS Sort Code 30-00-09, Account 11775391
□ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU
Swift (BIC): LOYDGB21013, Account 11775391
IBAN GB75 LOYD 3000 0911 7753 91
□ Cheque We can only accept US Dollar Cheques drawn on a US Bank.
□ Credit Card □ Visa □ MasterCard □ American Express
All credit card payments will be subject to standard credit card charges.
Card No: □□□□ □□□□ □□□□ □□□□
Valid From □□/□□ Expiry Date □□/□□
CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card
Cardholder’s Name:
Signature: Date:
I agree to be bound by SMi’s Terms and Conditions of Booking.
Card Billing Address (If different from above):
VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged
on Document portal and literature distribution for all UK customers and for those EU
Customers not supplying a registration number for their own country here.
______________________________________________________________________________________
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
□ Please contact me to book my hotel
Alternatively call us on +44 (0) 870 9090 711,
email: events@smi-online.co.uk or fax +44 (0) 870 9090 712
I cannot attend but would like to purchase access to the following
Document Portal/paper copy documentation Price Total
□ Access to the conference documentation
on the Document Portal £499.00 + VAT £598.80
□ The Conference Presentations – paper copy £499.00 - £499.00
(or only £300 if ordered with the Document Portal)
Unique Reference Number
Our Reference LVP-261
EARLY BIRD
DISCOUNT
□ Book by 30th June 2017 to receive $300 off the conference price
□ Book by 29th September 2017 to receive $100 off the conference price
DELEGATE DETAILS
Terms and Conditions of Booking
PAYMENT
VAT
DOCUMENTATION
VENUE Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
CONFERENCE PRICES
I would like to attend: (Please tick as appropriate) Fee
□ Conference 2 Workshops $2897.00
□ Conference 1 Workshop A □ B □ $2398.00
□ Conference only $1899.00
□ 2 Workshops $998.00
□ 1 Workshop only A □ B □ $499.00
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees $1598 + VAT $1917.60
The conference fee includes refreshments, lunch, conference papers, and access to
the Document Portal. Presentations that are available for download will be subject to
distribution rights by speakers. Please note that some presentations may not be available
for download. Access information for the document portal will be sent to the e-mail
address provided during registration. Details are sent within 24 hours post conference.