Reliance and Recognitions (GMP Inspections)
•
0 likes•125 views
Cooperation between regulatory authorities is essential for managing the complex global drug supply chain. The EU and FDA signed a mutual recognition agreement on GMP inspections in 1998 to increase efficiency and oversight of drug manufacturing inspections. Starting in November 2017, the agreement fully took effect, allowing the EU and FDA to rely on each other's GMP inspections for drug manufacturers in initially 8 EU member states, reducing duplication of inspections. The agreement is aimed at strengthening inspections and oversight while allowing for a more practical management of resources.
Report
Share
Report
Share
Download to read offline
Recommended
Case Study 3
This document discusses a case study about quality agreements between contract manufacturers and owners. It notes that the manufacturer's quality unit lacked adequate procedures and that the owner released drugs without test reports or confirmation of quality compliance. The document emphasizes that quality agreements must ensure GMP compliance through oversight programs and testing, as manufacturing drugs in a compliant environment is not enough without quality surveillance. Manufacturers, packagers, and testing laboratories acting as contractors should be held to the same compliance standards as they are an extension of the manufacturer.
Best Practices in Managing Global Supplier and Item Risks
How do you best manage global supplier and item risks?
According to Howard Popoola, VP of Quality Assurance at Topco Associates LLC, a 49 retailer member-owned cooperative with over $140 billion in combined annual revenue, and who has responsibility for the safety and quality of over 80,000 SKUs, “you have to be creative.”
Tune into our webinar with Mr. Popoola to learn how decide which suppliers to focus on, and which products should get your added attention.
Learn about:
- Risk classification
- Frequency of attention
- Pre-receipt sample testing
- Domestic vs. foreign-sourced considerations
- At-source testing and validation
- Pre-shipment inspection programs
- Specifications management
- Putting the consumer first!
TO DOWNLOAD: http://www.tracegains.com/webinar-best-practices-in-managing-global-supplier-and-item-risks
Your Best Recall is the One You Never Have to Do
This document discusses product recalls and the importance of managing quality across the supply chain. It notes that recalls have significantly increased since 2006 and about half are due to issues with suppliers or contract manufacturers. Recalls can cost companies between $10-90 million on average. The document then provides an example of the peanut corporation of America recall that cost over $1 billion. It emphasizes that identifying issues earlier in the supply chain reduces costs according to Deming's 1-10-100 rule. The rest of the document discusses how companies can implement strategies like HACCP and supplier relationship management to proactively monitor quality and ensure compliance across the extended supply chain using a quality management system.
Supplier Quality Engineer - Job Decription - 11132014
The Supplier Quality Engineer is responsible for conducting all engineering functions related to supplier quality to support company goals. Key duties include reviewing supplier non-conformances, dispositioning defective material, tracking supplier performance, auditing suppliers, and implementing quality policies and procedures. The ideal candidate has a degree in quality management or engineering, 2 years of manufacturing experience, strong problem solving skills, and proficiency with quality and office software.
Supplier qualification
This document discusses the importance of certifying vendors that supply raw materials for pharmaceutical manufacturing. Certification helps ensure high quality, safe medicines by preventing issues like contamination, recalls, deaths, and adverse events. It outlines six key steps in the vendor qualification process: 1) supplier selection, 2) due diligence, 3) quality assessment, 4) change control and production assessment, 5) supply chain security, and 6) ongoing monitoring and evaluation. Proper vendor certification and qualification of suppliers is necessary to maintain compliance and minimize risks to patients.
Quality metrics
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
Vendor qualification flow chart
Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs)
used as starting materials in the production of these products is subject to strict good
manufacturing practice regulations that are designed to ensure their quality, safety and
efficacy. This ensures that patients worldwide and at any time can have confidence in the
quality, safety and efficacy of medicines.
The cGMP regulations for final medicinal products are clearly defined in each country
and region. The content of the regulations may vary but the objectives are the same:
- To deliver high quality, safe medicines manufactured and distributed following
controlled procedures to treat diseases and
- To prevent deaths, serious illnesses, adverse events or product recalls resulting from
deficiencies in the manufacturing and distribution processes.
While in the vast majority of cases, the pharmaceutical industry, under the oversight of
the Regulatory Authorities and inspectorates consistently applies appropriate cGMP
practices,
Quality metrics ppt_v.kumar
"Quality Metrics" not only helpful US FDA, moreover helpful for all pharmaceutical industries.
Quality metrics are helpful for Chairman, MD, CEO & higher management to evaluate & know the firm performance (*Indirectly different department employees performance & productivity).
Recommended
Case Study 3
This document discusses a case study about quality agreements between contract manufacturers and owners. It notes that the manufacturer's quality unit lacked adequate procedures and that the owner released drugs without test reports or confirmation of quality compliance. The document emphasizes that quality agreements must ensure GMP compliance through oversight programs and testing, as manufacturing drugs in a compliant environment is not enough without quality surveillance. Manufacturers, packagers, and testing laboratories acting as contractors should be held to the same compliance standards as they are an extension of the manufacturer.
Best Practices in Managing Global Supplier and Item Risks
How do you best manage global supplier and item risks?
According to Howard Popoola, VP of Quality Assurance at Topco Associates LLC, a 49 retailer member-owned cooperative with over $140 billion in combined annual revenue, and who has responsibility for the safety and quality of over 80,000 SKUs, “you have to be creative.”
Tune into our webinar with Mr. Popoola to learn how decide which suppliers to focus on, and which products should get your added attention.
Learn about:
- Risk classification
- Frequency of attention
- Pre-receipt sample testing
- Domestic vs. foreign-sourced considerations
- At-source testing and validation
- Pre-shipment inspection programs
- Specifications management
- Putting the consumer first!
TO DOWNLOAD: http://www.tracegains.com/webinar-best-practices-in-managing-global-supplier-and-item-risks
Your Best Recall is the One You Never Have to Do
This document discusses product recalls and the importance of managing quality across the supply chain. It notes that recalls have significantly increased since 2006 and about half are due to issues with suppliers or contract manufacturers. Recalls can cost companies between $10-90 million on average. The document then provides an example of the peanut corporation of America recall that cost over $1 billion. It emphasizes that identifying issues earlier in the supply chain reduces costs according to Deming's 1-10-100 rule. The rest of the document discusses how companies can implement strategies like HACCP and supplier relationship management to proactively monitor quality and ensure compliance across the extended supply chain using a quality management system.
Supplier Quality Engineer - Job Decription - 11132014
The Supplier Quality Engineer is responsible for conducting all engineering functions related to supplier quality to support company goals. Key duties include reviewing supplier non-conformances, dispositioning defective material, tracking supplier performance, auditing suppliers, and implementing quality policies and procedures. The ideal candidate has a degree in quality management or engineering, 2 years of manufacturing experience, strong problem solving skills, and proficiency with quality and office software.
Supplier qualification
This document discusses the importance of certifying vendors that supply raw materials for pharmaceutical manufacturing. Certification helps ensure high quality, safe medicines by preventing issues like contamination, recalls, deaths, and adverse events. It outlines six key steps in the vendor qualification process: 1) supplier selection, 2) due diligence, 3) quality assessment, 4) change control and production assessment, 5) supply chain security, and 6) ongoing monitoring and evaluation. Proper vendor certification and qualification of suppliers is necessary to maintain compliance and minimize risks to patients.
Quality metrics
Quality Metrics are used to monitor the overall quality of pharmaceutical products and helps to improve product quality and implementing the culture in manufacturing facility.
Vendor qualification flow chart
Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs)
used as starting materials in the production of these products is subject to strict good
manufacturing practice regulations that are designed to ensure their quality, safety and
efficacy. This ensures that patients worldwide and at any time can have confidence in the
quality, safety and efficacy of medicines.
The cGMP regulations for final medicinal products are clearly defined in each country
and region. The content of the regulations may vary but the objectives are the same:
- To deliver high quality, safe medicines manufactured and distributed following
controlled procedures to treat diseases and
- To prevent deaths, serious illnesses, adverse events or product recalls resulting from
deficiencies in the manufacturing and distribution processes.
While in the vast majority of cases, the pharmaceutical industry, under the oversight of
the Regulatory Authorities and inspectorates consistently applies appropriate cGMP
practices,
Quality metrics ppt_v.kumar
"Quality Metrics" not only helpful US FDA, moreover helpful for all pharmaceutical industries.
Quality metrics are helpful for Chairman, MD, CEO & higher management to evaluate & know the firm performance (*Indirectly different department employees performance & productivity).
8.1 Cost of Quality
The cost of quality (COQ) refers to the cumulative costs required to ensure a project meets defined standards, and includes prevention costs to stop errors proactively, appraisal costs to check for errors, and failure costs associated with errors that actually occur. Prevention costs relate to activities that prevent poor quality, appraisal costs cover evaluation and testing, and failure costs stem from nonconformance to stakeholder needs.
Standard operating procedures, records and good practice of production
This document discusses standard operating procedures, documentation, and record keeping in the pharmaceutical industry. It defines key terms like standard operating procedure, documentation, and different types of records. It explains the importance of SOPs and documentation in ensuring uniformity, quality control, and compliance. It also outlines the typical contents, types, and processes involved in SOPs, documentation and maintaining different records like batch records, quality control records, and distribution records.
Quality metrices
This presentation discusses quality metrics and how the pharmaceutical industry uses metrics. It defines quality metrics as elements that evaluate processes like customer satisfaction and defects. Metrics can help improve quality and productivity. The FDA requires metrics to evaluate manufacturing quality and reduce drug shortages. Guidelines like ICH Q8-Q11 provide a framework for using metrics flexibly to focus on quality. Leading and lagging metrics are discussed.
Training Session on Good Manufacturing Practices of the 21st Century
This document outlines areas for research to advance Good Manufacturing Practices in the 21st century. It discusses investigating and evaluating novel manufacturing methods and their impact on product failure rates and quality. It also addresses developing improved analytical methods to evaluate product quality using emerging technologies, and developing sensitive methods to detect and reduce microbial contamination. The overall goals are to enable development and evaluation of important manufacturing improvements, lower the cost of manufacturing, and improve the ability of regulatory agencies to ensure safety, quality and efficacy.
FDA Warning Letters Study
This document analyzes FDA warning letters issued between 2007 and June 2014. It finds that warning letters increased 78% from 2007 to 2013, with pharmaceutical/biotech, medical devices, and food/beverage industries receiving 95.72% of letters. Recent decreases in letters are likely due to reduced FDA funding and inspection freezes. The document predicts letters will rise in 2015 with a proposed FDA budget increase.
Updated Resume
This document is a resume for Apsaran.A seeking a position as a quality engineer. It summarizes her educational qualifications including a B.E in Mechanical Engineering, and over 4 years of work experience in quality assurance roles in the auto and home appliance industries. Her technical skills include APQP, PPAP, FMEA, data analysis tools, problem solving methods, and continuous improvement techniques like Six Sigma. Her responsibilities have involved supplier quality management, auditing, root cause analysis, and achieving quality targets through process improvements.
ICHQ7 & Q11 (7 of 7)
The document discusses control strategies for pharmaceutical manufacturing processes as outlined in ICH Q7 and Q11 guidelines. It notes that control strategies should be based on current product and process understanding to ensure quality and performance. Traditionally, control strategies focused on set points and operating ranges, but an enhanced approach calls for more systematic identification of variability sources, increased process understanding, and flexibility in operating parameters. The document also assigns a 10-hour take-home assignment analyzing control strategies and case studies of API manufacturing failures.
QC-Manual
This quality control manual provides definitions and guidance for quality assurance processes. It outlines key terms like quality manual, efficiency, effectiveness, continual improvement, and quality policy. It describes the benefits of authorization like increased reliability and production. The manual establishes organizational roles and responsibilities and defines inspection, testing, and procedures. It presents a quality assurance process that includes calibration, welding control, material control, repair and alteration, and examinations and inspections. Finally, it provides details on inspection points and controlling fabrication.
Creating the Case for Enterprise Quality
Organizations in highly regulated industries continue to face pressure to maintain the highest level of quality in every facet of their operations, while at the same time reducing costs and maintaining margins. This presentation from Sparta Systems describes what Enterprise Quality Management Systems (EQMS) can do for these organizations.
Impact and Influence of Regulatory Changes to the Pharmaceutical Contract Man...
How the adoption of the PIC/S GMP code by the Australian Therapeutic Goods Administration (TGA) will impact pharmaceutical companies who use contract manufacturers.
Presentation discusses the regulatory obligations and how quality risk management should be used.
Quality Control vs Quality Assurance
The most confusing thing for newbies in the world of quality is quality control and quality assurance, here i am trying to explain the difference between the both
Apsaran updated_2
Apsaran.A is seeking a position as a quality engineer to utilize their 4.5 years of experience in quality assurance and process improvement. They have a B.E. in Mechanical Engineering and expertise in sheet metal fabrication, stamping, and PU foaming. Their technical skills include APQP, PPAP, FMEA, data analysis tools, problem solving methods, and software like Excel. They have worked as a quality engineer at Samsung and Elcon, focusing on reducing scrap and costs, improving material handling, and training operators.
Excipient Auditing
The document discusses good manufacturing practices (GMP) for excipient suppliers. It provides guidance on qualifying excipient suppliers, ensuring traceability of excipients throughout their lifecycle, assessing supplier GMP conformance, and evaluating significant changes in excipients. The document also summarizes International Pharmaceutical Excipients Council (IPEC) guides on GMP auditing practices for excipient manufacturers and distributors.
The Traceability Disconnect: FSMA 204 -vs- “The Industry”
Learn the disconnect between regulatory traceability requirements & industry standards; how KDEs needed for recall resolution compare to those in FSMA 204; & ways to fortify your traceability system
Food Safety Challenges in a Post Horsegate Post Brexit World
Regulatory product recalls are up 80% in the past two years and scrutiny on supply chains has resulted in additional work for Quality and Technical Managers.
The effects of Brexit are already being felt by businesses and consumers alike. The food industry has never been subjected to these levels of change in such a short period of time. During this short talk we will look at how the uncertainty of Brexit is likely to affect food safety for food and drink manufacturers on top of the recent ‘horsegate’ changes to BRC Global Food Standard Issue 7.
The talk will be based around the results of a study we have recently carried out which focused on understanding the issues food and drinks businesses are actually working on to improve food safety in a rapidly changing compliance landscape. We will highlight the top challenges reported in our survey and draw conclusions to inspire the audience to prioritise the issues they are working on and understand the strategies required to manage these more effectively.
Quality assurance
This document discusses quality assurance in the pharmaceutical industry. It defines key terms like quality assurance (QA) and quality control (QC), and explains their objectives. QA aims to achieve product realization and continual improvement through monitoring processes and products, corrective actions, and management reviews. QC ensures products are consistently manufactured and tested according to quality standards. The document also identifies major risks to pharmaceutical production and key factors for achieving an effective quality management system, such as customer focus, leadership, and continuous improvement.
Quality assurance program
This document defines quality and quality assurance in healthcare. It outlines the objectives of quality assurance as ensuring quality patient care and demonstrating efforts to provide the best results. General principles of quality assurance are that services should be fit for purpose and mistakes eliminated. Quality assurance involves retrospective, concurrent reviews and has strategic, tactical, and operational components. Key steps in the quality assurance process include planning, setting standards, monitoring quality, identifying problems, analyzing issues, developing solutions, and evaluating improvements. Ensuring quality aims to improve health outcomes, meet expectations, use resources efficiently, standardize care, and fulfill ethical duties while factors like weak leadership and lack of resources can hinder quality assurance efforts.
Supplier Quality Engineer
The Supplier Quality Engineer is responsible for assessing supplier capabilities to ensure effective quality systems are in place to facilitate flawless new product launches. This includes conducting supplier assessments, analyzing control plans and issues, and participating in issue resolution through the first 6 months of production. The role aims to qualify suppliers and verify quality requirements are met for new product introductions.
PBergin-Holbrook resume 2016
Paula Bergin-Holbrook has over 25 years of experience in quality assurance for the biotechnology and pharmaceutical industries. She has extensive experience with GMP quality systems, auditing, CAPA management, and ensuring regulatory compliance. Her background includes roles with increasing responsibility at companies such as Nuclea Diagnostics, Shire, Genzyme, Genentech, and Biomerieux.
Assessing the compliance of your food supply chain--an integrated approach
See the results of EtQ's supplier workshop and learn how to asses the compliance of your food supply chain.
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...
This document provides an overview of BizBites, a business intelligence and technology solutions provider based in the UK and India since 2004 and 2011 respectively. It also describes tQmlab, one of BizBites' premier management systems for GxP operations and enabling regulatory submissions. tQmlab delivers improved productivity for QA/QC labs through customized workflows for quality control, stability testing, product release testing, and post-release quality testing. It also enables process analytical technology controls in pharmaceutical manufacturing and analytical processes.
Good Manufacturing Practices (GMP)- Purpose and Principles
It'a a presentation on GMP prepared for the seminar at the college. Includes general basics of GMP with simple understanding.
More Related Content
What's hot
8.1 Cost of Quality
The cost of quality (COQ) refers to the cumulative costs required to ensure a project meets defined standards, and includes prevention costs to stop errors proactively, appraisal costs to check for errors, and failure costs associated with errors that actually occur. Prevention costs relate to activities that prevent poor quality, appraisal costs cover evaluation and testing, and failure costs stem from nonconformance to stakeholder needs.
Standard operating procedures, records and good practice of production
This document discusses standard operating procedures, documentation, and record keeping in the pharmaceutical industry. It defines key terms like standard operating procedure, documentation, and different types of records. It explains the importance of SOPs and documentation in ensuring uniformity, quality control, and compliance. It also outlines the typical contents, types, and processes involved in SOPs, documentation and maintaining different records like batch records, quality control records, and distribution records.
Quality metrices
This presentation discusses quality metrics and how the pharmaceutical industry uses metrics. It defines quality metrics as elements that evaluate processes like customer satisfaction and defects. Metrics can help improve quality and productivity. The FDA requires metrics to evaluate manufacturing quality and reduce drug shortages. Guidelines like ICH Q8-Q11 provide a framework for using metrics flexibly to focus on quality. Leading and lagging metrics are discussed.
Training Session on Good Manufacturing Practices of the 21st Century
This document outlines areas for research to advance Good Manufacturing Practices in the 21st century. It discusses investigating and evaluating novel manufacturing methods and their impact on product failure rates and quality. It also addresses developing improved analytical methods to evaluate product quality using emerging technologies, and developing sensitive methods to detect and reduce microbial contamination. The overall goals are to enable development and evaluation of important manufacturing improvements, lower the cost of manufacturing, and improve the ability of regulatory agencies to ensure safety, quality and efficacy.
FDA Warning Letters Study
This document analyzes FDA warning letters issued between 2007 and June 2014. It finds that warning letters increased 78% from 2007 to 2013, with pharmaceutical/biotech, medical devices, and food/beverage industries receiving 95.72% of letters. Recent decreases in letters are likely due to reduced FDA funding and inspection freezes. The document predicts letters will rise in 2015 with a proposed FDA budget increase.
Updated Resume
This document is a resume for Apsaran.A seeking a position as a quality engineer. It summarizes her educational qualifications including a B.E in Mechanical Engineering, and over 4 years of work experience in quality assurance roles in the auto and home appliance industries. Her technical skills include APQP, PPAP, FMEA, data analysis tools, problem solving methods, and continuous improvement techniques like Six Sigma. Her responsibilities have involved supplier quality management, auditing, root cause analysis, and achieving quality targets through process improvements.
ICHQ7 & Q11 (7 of 7)
The document discusses control strategies for pharmaceutical manufacturing processes as outlined in ICH Q7 and Q11 guidelines. It notes that control strategies should be based on current product and process understanding to ensure quality and performance. Traditionally, control strategies focused on set points and operating ranges, but an enhanced approach calls for more systematic identification of variability sources, increased process understanding, and flexibility in operating parameters. The document also assigns a 10-hour take-home assignment analyzing control strategies and case studies of API manufacturing failures.
QC-Manual
This quality control manual provides definitions and guidance for quality assurance processes. It outlines key terms like quality manual, efficiency, effectiveness, continual improvement, and quality policy. It describes the benefits of authorization like increased reliability and production. The manual establishes organizational roles and responsibilities and defines inspection, testing, and procedures. It presents a quality assurance process that includes calibration, welding control, material control, repair and alteration, and examinations and inspections. Finally, it provides details on inspection points and controlling fabrication.
Creating the Case for Enterprise Quality
Organizations in highly regulated industries continue to face pressure to maintain the highest level of quality in every facet of their operations, while at the same time reducing costs and maintaining margins. This presentation from Sparta Systems describes what Enterprise Quality Management Systems (EQMS) can do for these organizations.
Impact and Influence of Regulatory Changes to the Pharmaceutical Contract Man...
How the adoption of the PIC/S GMP code by the Australian Therapeutic Goods Administration (TGA) will impact pharmaceutical companies who use contract manufacturers.
Presentation discusses the regulatory obligations and how quality risk management should be used.
Quality Control vs Quality Assurance
The most confusing thing for newbies in the world of quality is quality control and quality assurance, here i am trying to explain the difference between the both
Apsaran updated_2
Apsaran.A is seeking a position as a quality engineer to utilize their 4.5 years of experience in quality assurance and process improvement. They have a B.E. in Mechanical Engineering and expertise in sheet metal fabrication, stamping, and PU foaming. Their technical skills include APQP, PPAP, FMEA, data analysis tools, problem solving methods, and software like Excel. They have worked as a quality engineer at Samsung and Elcon, focusing on reducing scrap and costs, improving material handling, and training operators.
Excipient Auditing
The document discusses good manufacturing practices (GMP) for excipient suppliers. It provides guidance on qualifying excipient suppliers, ensuring traceability of excipients throughout their lifecycle, assessing supplier GMP conformance, and evaluating significant changes in excipients. The document also summarizes International Pharmaceutical Excipients Council (IPEC) guides on GMP auditing practices for excipient manufacturers and distributors.
The Traceability Disconnect: FSMA 204 -vs- “The Industry”
Learn the disconnect between regulatory traceability requirements & industry standards; how KDEs needed for recall resolution compare to those in FSMA 204; & ways to fortify your traceability system
Food Safety Challenges in a Post Horsegate Post Brexit World
Regulatory product recalls are up 80% in the past two years and scrutiny on supply chains has resulted in additional work for Quality and Technical Managers.
The effects of Brexit are already being felt by businesses and consumers alike. The food industry has never been subjected to these levels of change in such a short period of time. During this short talk we will look at how the uncertainty of Brexit is likely to affect food safety for food and drink manufacturers on top of the recent ‘horsegate’ changes to BRC Global Food Standard Issue 7.
The talk will be based around the results of a study we have recently carried out which focused on understanding the issues food and drinks businesses are actually working on to improve food safety in a rapidly changing compliance landscape. We will highlight the top challenges reported in our survey and draw conclusions to inspire the audience to prioritise the issues they are working on and understand the strategies required to manage these more effectively.
Quality assurance
This document discusses quality assurance in the pharmaceutical industry. It defines key terms like quality assurance (QA) and quality control (QC), and explains their objectives. QA aims to achieve product realization and continual improvement through monitoring processes and products, corrective actions, and management reviews. QC ensures products are consistently manufactured and tested according to quality standards. The document also identifies major risks to pharmaceutical production and key factors for achieving an effective quality management system, such as customer focus, leadership, and continuous improvement.
Quality assurance program
This document defines quality and quality assurance in healthcare. It outlines the objectives of quality assurance as ensuring quality patient care and demonstrating efforts to provide the best results. General principles of quality assurance are that services should be fit for purpose and mistakes eliminated. Quality assurance involves retrospective, concurrent reviews and has strategic, tactical, and operational components. Key steps in the quality assurance process include planning, setting standards, monitoring quality, identifying problems, analyzing issues, developing solutions, and evaluating improvements. Ensuring quality aims to improve health outcomes, meet expectations, use resources efficiently, standardize care, and fulfill ethical duties while factors like weak leadership and lack of resources can hinder quality assurance efforts.
Supplier Quality Engineer
The Supplier Quality Engineer is responsible for assessing supplier capabilities to ensure effective quality systems are in place to facilitate flawless new product launches. This includes conducting supplier assessments, analyzing control plans and issues, and participating in issue resolution through the first 6 months of production. The role aims to qualify suppliers and verify quality requirements are met for new product introductions.
PBergin-Holbrook resume 2016
Paula Bergin-Holbrook has over 25 years of experience in quality assurance for the biotechnology and pharmaceutical industries. She has extensive experience with GMP quality systems, auditing, CAPA management, and ensuring regulatory compliance. Her background includes roles with increasing responsibility at companies such as Nuclea Diagnostics, Shire, Genzyme, Genentech, and Biomerieux.
Assessing the compliance of your food supply chain--an integrated approach
See the results of EtQ's supplier workshop and learn how to asses the compliance of your food supply chain.
What's hot (20)
Standard operating procedures, records and good practice of production
Standard operating procedures, records and good practice of production
Training Session on Good Manufacturing Practices of the 21st Century
Training Session on Good Manufacturing Practices of the 21st Century
Impact and Influence of Regulatory Changes to the Pharmaceutical Contract Man...
Impact and Influence of Regulatory Changes to the Pharmaceutical Contract Man...
The Traceability Disconnect: FSMA 204 -vs- “The Industry”
The Traceability Disconnect: FSMA 204 -vs- “The Industry”
Food Safety Challenges in a Post Horsegate Post Brexit World
Food Safety Challenges in a Post Horsegate Post Brexit World
Assessing the compliance of your food supply chain--an integrated approach
Assessing the compliance of your food supply chain--an integrated approach
Similar to Reliance and Recognitions (GMP Inspections)
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...
This document provides an overview of BizBites, a business intelligence and technology solutions provider based in the UK and India since 2004 and 2011 respectively. It also describes tQmlab, one of BizBites' premier management systems for GxP operations and enabling regulatory submissions. tQmlab delivers improved productivity for QA/QC labs through customized workflows for quality control, stability testing, product release testing, and post-release quality testing. It also enables process analytical technology controls in pharmaceutical manufacturing and analytical processes.
Good Manufacturing Practices (GMP)- Purpose and Principles
It'a a presentation on GMP prepared for the seminar at the college. Includes general basics of GMP with simple understanding.
Resume
Jyoti Kothari has over 24 years of experience in quality assurance roles in the pharmaceutical industry. She currently works as a Validation Specialist at Nesher Pharmaceuticals, where she is responsible for equipment qualification and validation activities. Previously, she worked at Cadila Healthcare as an Associate Manager of Quality Assurance Compliance, where she led quality assurance teams and managed regulatory inspections and audits. She has a strong background in GMP compliance and quality system management.
Rajamani Sep 16
C. Rajamani Iyer has over 15 years of experience in quality assurance roles in the pharmaceutical industry. He currently works as a Senior Quality Assurance Manager for a large pharmaceutical company, where he manages a team of 10. Previously he has held roles as Supplier Manager QA and Manager QA. He has expertise in areas such as quality assurance, manufacturing assurance, process audits, and supplier audits. He has experience working with regulatory agencies like MHRA, TGA, Health Canada, and USFDA.
OARO 11 Feb 2017
This document discusses quality systems in manufacturing facilities. It begins with an overview of fundamental quality issues that have led to tragedies in healthcare products. The discussion then focuses on quality attributes and how ensuring safety, efficacy, identity, purity, strength and consistency are critical. Several case studies on quality failures at manufacturing sites are presented to demonstrate how deficiencies can occur when quality systems are not adequately implemented and maintained. The importance of compliance with good manufacturing practices to ensure quality is built into the manufacturing process is emphasized.
GRM 2011: A quality management framework for integrated plant breeding
GRM 2011: A quality management framework for integrated plant breedingCGIAR Generation Challenge Programme
The document discusses implementing a quality assurance framework for plant breeding. It outlines benefits like increased competitiveness, knowledge transfer within institutes, and improved partnerships. Examples of relevant quality standards like ISO 9001 and ISO 17025 are provided. Implementing a framework requires documenting processes, training, equipment records, and validating data. Buy-in requires incentives for compliance since currently consequences are lacking. The framework must be tailored to different partners' capacities and emergencies may require early solutions. Quality systems can demonstrate competence and improve projects if expectations are appropriately set.Resume
Jyoti Kothari has over 24 years of experience in quality assurance, manufacturing, and packaging in the pharmaceutical industry. She currently works as a Validation Specialist at Nesher Pharmaceuticals, where she is responsible for equipment qualification and preparing documentation. Previously, she was Associate Manager of Quality Assurance Compliance at Cadila Healthcare, where she led audits, reviewed documents, and ensured regulatory compliance. She has a diploma in pharmacy and is eligible to work in the US.
Mom resume
Jyoti Kothari has over 24 years of experience in quality assurance, manufacturing, and packaging in the pharmaceutical industry. She currently works as a Validation Specialist at Nesher Pharmaceuticals, where she is responsible for equipment qualification and preparing documentation. Previously, she was Associate Manager of Quality Assurance Compliance at Cadila Healthcare, where she led audits, reviewed documents, and ensured regulatory compliance. She has a diploma in pharmacy and is eligible to work in the US.
Pharmaceutical validations- research and reviews journal of pharmaceutical qu...
Pharmaceutical validations- research and reviews journal of pharmaceutical qu...M. Luisetto Pharm.D.Spec. Pharmacology
This document discusses pharmaceutical validations. It begins with an abstract that defines quality assurance and validation in the pharmaceutical industry. The introduction provides more context on validation, stating that its goal is to reliably produce high quality products at low cost. The body of the document then discusses various aspects of validation including its significance, preparation, documentation, methods (prospective validation is described), and what should be included in prospective validation. Overall, the document provides an overview of pharmaceutical validation processes and requirements.Emerging Phenomena & Challenges
The document discusses emerging challenges related to ICH Q8 and Q10 implementation, including increased risk and non-compliance due to process variability. It also discusses how quality inspectors and assessors can evaluate product control strategy, quality by design, manufacturing processes, and change management systems. The rest of the document focuses on knowledge management, data integrity, and quality metrics as indicators of operational reliability and quality culture. Key quality metrics discussed include lot acceptance rate, product quality complaint rate, right first time rate, invalidated OOS rate, APR/PQR on time rate, CAPA rate, and ability to initiate voluntary CAPA.
Bilcare_GCS Quality and Regulatory Overiew
Bilcare is committed to providing innovative clinical trial material supply services globally according to quality and regulatory standards. It offers services including clinical trial manufacturing, packaging, labeling, sourcing of drugs, and storage and distribution. Bilcare aims to provide cost-effective and creative solutions through strategic partnerships to help customers succeed. It focuses on customer satisfaction, continual self-improvement, and compliance with regulations like cGMP, GCP, and ISO 9001. Bilcare works to improve through learning from audits and implementing systems improvements.
Quality & compliance excellence in pharmaceuticals
Quality can be defined in several ways including conformance to specifications, fitness for use, and value for price paid. It is judged based on factors like performance, reliability, and support services provided. Pharmaceutical products have higher quality standards and more regulations compared to consumer goods due to their intended use and potential risks. Ensuring compliance with various quality guidelines is important for patient safety and involves establishing quality systems, policies, procedures, documentation, and ongoing assessments like audits and corrective actions. Non-compliance can result in issues like complaints, recalls, and regulatory actions.
shyam resume new
Shyam KSG has over 20 years of experience in quality assurance for pharmaceutical companies. He currently works as an Associate Director of Quality Assurance at Agila Specialties, where he oversees quality compliance and systems. Prior roles include executive roles in quality assurance and quality control. He has expertise in aseptic processing, validations, compliance with regulatory agencies like USFDA and MHRA, handling audits, and leading cross-functional teams.
Qa tools and techniques
This document provides an overview of quality assurance tools and techniques used in the pharmaceutical industry. It defines quality assurance and discusses its advantages in providing high quality drugs and preventing defects. Disadvantages include perfection being difficult and limits being set. Tools covered include total quality management, quality control systems, documentation, and validation. Six sigma methodology is also described as a quality assurance technique. The roles and approaches of six sigma are explained. In conclusion, quality assurance is presented as an important preventative activity for quality improvement through management and employee development.
Pharmaceutical Good Manufacturing Practices
When you are in healthcare, Then GMP is must. Regulatory philosophy for product Quality have been changed from "Quality by Testing QbT" to "Quality by Design QbD". Quality is to be built in product and that only can be done by GMP.
2013 Year of Pharmaceutical Serialization - Get it Right
Pharmaceutical serialization en mass will occur in 2013 due to US and es-US regulations to track products at the item level. Michael Stewart of PharmTech Inc. shares his insight into the project Management pitfalls and allows you to use his learning curve working with top 10 pharmaceutical manufacturers, contract manufacturers and virtual manufactures to get ROI and business value in addition to compliance. Turn a perceived cost into an investment.
Proposed Supplier Qualification Policy
On the occasion of Discussion Forum on ICH Q7 & ICH Q11 of more than 450 experienced practicing professionals gathering of pharmaceutical manufacturing industry scheduled at ICCBS, University of Karachi organized by CCK on 23 April 2017
Experience guide to or implementation and compliance 2015
Ready to kick-off a compliance project? Don’t miss this webinar; leverage our experience to accelerate your compliance programs. Understand the certification options. Gain insight to assist your organization maintain compliance after project completion. Understand how certification and partner communication can protect your organization.
Gmp 1
This webinar discusses establishing a reduced testing program for incoming components in accordance with GMP quality principles and regulations. It will review the reduced testing lifecycle, including specifications, supplier qualification, auditing, and validation. Examples will demonstrate how to design systems to reduce costs while ensuring compliance. Attendees will learn how to qualify suppliers, control specifications, and reduce testing while maintaining quality. The speaker has 30+ years of experience implementing quality systems and will discuss applying quality assurance principles to medical devices and pharmaceuticals.
Lecture 2: QA and Qc in Pharma Industry
Quality assurance and quality control play important roles in the pharmaceutical industry to ensure product safety and efficacy. Quality assurance focuses on preventing defects through process improvement and monitoring, while quality control identifies defects through testing of raw materials, in-process materials and finished products. Both functions are necessary to consistently deliver high quality products that do not compromise consumer health. Key responsibilities of quality assurance include overseeing quality systems, monitoring validation activities and investigating issues like deviations. Quality control responsibilities involve testing, method validation, complaint investigation and stability studies. Together quality assurance and quality control form a quality culture from design through manufacturing and distribution.
Similar to Reliance and Recognitions (GMP Inspections) (20)
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...
Good Manufacturing Practices (GMP)- Purpose and Principles
Good Manufacturing Practices (GMP)- Purpose and Principles
GRM 2011: A quality management framework for integrated plant breeding
GRM 2011: A quality management framework for integrated plant breeding
Pharmaceutical validations- research and reviews journal of pharmaceutical qu...
Pharmaceutical validations- research and reviews journal of pharmaceutical qu...
Quality & compliance excellence in pharmaceuticals
Quality & compliance excellence in pharmaceuticals
2013 Year of Pharmaceutical Serialization - Get it Right
2013 Year of Pharmaceutical Serialization - Get it Right
Experience guide to or implementation and compliance 2015
Experience guide to or implementation and compliance 2015
More from Obaid Ali / Roohi B. Obaid
A Strategic Talk on Biologicals & Biotechnological Products
The document discusses anti-thymocyte globulin (ATG), which is used for acute organ rejection. ATG is produced from rabbits that are inoculated with human T lymphocytes to trigger an antibody response. The antibodies produced in rabbits are then extracted, purified, and administered to patients to kill arrays of lymphocytes. Developing a process to characterize the target globulin and transferring knowledge will help establish protein production. Key challenges include maintaining clean environments and aseptic extraction, purification, and filling processes.
Centre for Quality Sciences-Information File-2024.pdf
The document discusses establishing the OR Centre for Quality Sciences to provide consulting services to the pharmaceutical and biologics industries regarding quality, regulatory affairs, innovation, and technology. It aims to engage subject matter experts to support academia, industry, and government. The Centre will focus on shifting from a compliance to a quality culture and aligning with new regulatory expectations in a changing technological landscape with advances in areas like artificial intelligence and data sciences. It will provide training, reviews, audits, and other services to support quality systems, documentation practices, regulatory submissions, clinical trials, and more.
A Tragic Resistance to Learn.pdf
An article on contamination of Diethylene Glycol in Pharmaceuticals. Thanks to Dr. Ajaz S. Hussain for all teaching, sharing knowledge and supporting in professional development.
230930.pdf
The document announces a training on demonstrating a quality management system during inspections to be held on September 30, 2023 in Kotri, Sindh. It will provide participants with techniques for showcasing compliance and procedures when regulatory audits occur. A list of attendees is included but not summarized for brevity.
Demonstrate your QMS during Inspection-30 Sep 2023.pdf
The document provides tips for demonstrating a quality management system during an inspection. It advises being simple, clear, truthful, and confident when welcoming inspectors. Assign specific duties to staff and have flexibility. Listen fully to questions before responding, and don't argue - say you will look into issues. Practice mock inspections, recognize potential problems, and maintain your system daily.
Centre for Quality Sciences-2023
The document discusses the services provided by the Centre for Quality Sciences, which include designing new and upgrading existing pharmaceutical manufacturing facilities, conducting GMP audits and training, assisting with regulatory submissions, and providing consulting services regarding quality systems, data integrity, and compliance strategies. The Centre's vision is to shift the industry towards a quality culture through knowledge sharing and facilitating discussions to develop strategic roadmaps. It aims to help companies strengthen quality compliance and sustain their quality management systems in the changing regulatory landscape.
Track, Trace & Understand Science of Life from Real World Evidence.pdf
The document discusses biomarkers, which are measurable indicators of biological states or conditions. It describes biomarkers as tools that can help facilitate medical product development. The document outlines different types, categories, and descriptions of biomarkers. It discusses how biomarkers can be qualified and approved by regulatory agencies like the FDA for specific contexts of use. The document provides examples of biomarkers that have been used for various purposes, such as assessing disease diagnosis, treatment effectiveness, and safety. It also summarizes some biomarkers that have been qualified or considered for qualification by the FDA.
Confidence on Generics.pdf
1) The document discusses the evolution of ensuring drug quality from relying solely on testing to emphasizing proper manufacturing processes and controls.
2) It explains that without understanding the entire manufacturing process, one cannot say a drug is consistent in quality and purity or free of contamination.
3) Current good manufacturing practices (cGMP) help assure drug safety and efficacy by requiring facilities to control manufacturing operations through quality management systems and robust operating procedures.
Neurotoxicity & Neurodegenaration.pdf
The document discusses neurotoxicity and neurodegeneration in drug development. It notes that safety issues, especially related to the cardiovascular system and central nervous system, are among the most common reasons for drug development failure. Biomarkers for early detection of potential neurotoxicity could help improve success rates by facilitating safety screening earlier in the development process. The central nervous system is particularly vulnerable, as neurotoxicity is a frequent cause of failure in both pre-clinical and clinical phases of development.
Application of Data & AI in Pharma 4
Mr. Atiq ur Rahman has over 27 years of experience in pharmaceutical manufacturing and supply chain management. He has expertise in facility design, quality audits, and regulatory compliance. More recently, he has worked on data engineering, data acquisition, and applying data science concepts in pharmaceutical and other process industries. The presentation provides an overview of the industrial revolutions from Industry 1.0 to 5.0 and defines Pharma 4.0 as the convergence of people, systems, and data within a singular network powered by artificial intelligence. It discusses strategies for digital transformation and achieving digital maturity, including evaluating current technology needs and creating a roadmap with goals and timelines.
PICS-ICH
The document discusses the relationship between PIC/S and ICH and their roles in harmonizing GMP standards globally. PIC/S focuses specifically on GMP inspections and developing harmonized GMP standards and training inspectors. ICH focuses more broadly on safety, efficacy, quality and regulatory guidelines. Together they aim to promote reliance between regulatory authorities and open doors of trust through mutual recognition agreements and understanding of inspection systems. The document provides a comprehensive overview of their goals and collaboration to harmonize standards for patients worldwide.
Quality Affairs of Pharmaceuticals
The document discusses a presentation on quality issues observed by the FDA during inspections of pharmaceutical facilities in 2022. It notes the FDA observed deficiencies related to lack of written SOPs, insecure data, failure to investigate out of specification results, cleaning issues, and missing environmental monitoring programs. The document also presents a case study of a facility that had a significant media fill failure in November 2021 but did not initiate a recall until April 2022, exposing patients to risk. It describes poor aseptic techniques observed by FDA investigators during manufacturing operations.
120th Training Session - Unfortunate Wave of DEG Tragedy.pdf
The filling machine and HEPA filter located directly above the filling machine in the filling room were significantly discolored with an unknown substance. This indicates potential contamination issues that need to be investigated and addressed. Facilities should ensure machinery and equipment are properly cleaned and maintained to prevent contamination that could compromise product quality.
CQS Session - RO - 16 Oct 2022.pdf
The document discusses the pressure of real-world evidence on pharmaceutical regulatory science. It mentions the author's experience interacting with international regulatory agencies like the FDA, EU, Health Canada, and MHRA. It lists some references on topics like continuous manufacturing and real-time dissolution prediction. The document emphasizes that improving individual parts of a system will not improve the overall system, and that a systems approach to quality is needed.
GMP Session for Professional Development.pdf
This document provides information about an upcoming training session on Good Manufacturing Practices. The session will be held on October 16th in Karachi and will run from 9:00 am to 3:00 pm. It is aimed at pharmaceutical professionals with backgrounds in pharmacy, chemistry, microbiology and related fields. Experts from the US pharmaceutical industry will discuss advancements in manufacturing technology and emerging regulatory changes. The session will include tutorials, discussions, and Q&A to help participants better understand GMP requirements and ensure quality assurance. Participants will pay Rs. 10,000 or Rs. 5,000 depending on whether they are attending as part of their job. More details and contact information are provided.
Q & A - June - Sep 2022.pdf
This document contains questions and answers related to pharmaceutical quality and manufacturing. It discusses topics like clean hold time, dirty hold time, contamination control strategies, particles in injections, the differences between CMC, GMP, and continuous manufacturing. It also addresses questions about PIC/S, such as whether they issue membership, if inspections by one country are accepted by others, and that GMP certificates are issued by individual regulatory authorities rather than PIC/S.
Judging Science & Prior Knowledge Beyond the Line
This document discusses issues that may arise with generic drugs compared to innovator drugs. Bioequivalence studies only show equivalence at a single point in time and do not guarantee equivalence over the lifetime of the drug. Manufacturing the drug involves many variables like people, equipment, materials that could result in potency and dissolution differences compared to the innovator. The document provides data that showed increased hospitalization rates for certain generics compared to the innovator drug. It emphasizes the need for consistent quality manufacturing to ensure patient safety.
Maturing Drug Quality to Deliver Promise
The document discusses several topics related to improving drug quality including:
1) Evidence from clinical trials and real world use is key to determining drug effectiveness but quality can deteriorate after marketing authorization without a strong quality management system.
2) Errors must be eliminated through quality by design in development and operational excellence, and companies must continuously improve rather than just fixing problems.
3) Digital transformation, identifying critical quality attributes, and moving to more flexible and integrated quality systems will help address issues and improve patient outcomes.
PQRS 2022 - Education
This document appears to be a scanned receipt from a restaurant in New York City listing various food and drink items purchased, with a subtotal of $86.62 and total including tax of $97.45. The receipt details a variety of appetizers, entrees, drinks and desserts ordered for multiple guests.
4 - GMP June 2022 - CQS.pdf
This document discusses key elements of good manufacturing practices (GMP) for pharmaceutical manufacturing. It covers topics like building layout, equipment, utilities, documentation, materials, production processes, packaging, quality systems, facilities, laboratories and ensuring the safety, efficacy and quality of pharmaceutical products. The overall message is that GMP provides a foundation and framework to establish process and quality control, validate operations, continuously improve and ultimately ensure that pharmaceutical products meet their intended quality standards.
More from Obaid Ali / Roohi B. Obaid (20)
A Strategic Talk on Biologicals & Biotechnological Products
A Strategic Talk on Biologicals & Biotechnological Products
Centre for Quality Sciences-Information File-2024.pdf
Centre for Quality Sciences-Information File-2024.pdf
Demonstrate your QMS during Inspection-30 Sep 2023.pdf
Demonstrate your QMS during Inspection-30 Sep 2023.pdf
Track, Trace & Understand Science of Life from Real World Evidence.pdf
Track, Trace & Understand Science of Life from Real World Evidence.pdf
120th Training Session - Unfortunate Wave of DEG Tragedy.pdf
120th Training Session - Unfortunate Wave of DEG Tragedy.pdf
Recently uploaded
Comparing Stability and Sustainability in Agile Systems
Copy of the presentation given at XP2024 based on a research paper.
In this paper we explain wat overwork is and the physical and mental health risks associated with it.
We then explore how overwork relates to system stability and inventory.
Finally there is a call to action for Team Leads / Scrum Masters / Managers to measure and monitor excess work for individual teams.
Employment Practices Regulation and Multinational Corporations
Employment Practices Regulation and Multinational Corporations
Strategic decision making within MNCs constrained or determined by the implementation of laws and codes of practice and by pressure from political actors. Managers in MNCs have to make choices that are shaped by gvmt. intervention and the local economy.
原版制作(澳洲WSU毕业证书)西悉尼大学毕业证文凭证书一模一样
学校原件一模一样【微信：741003700 】《(澳洲WSU毕业证书)西悉尼大学毕业证、文凭证书》【微信：741003700 】学位证，留信认证（真实可查，永久存档）原件一模一样纸张工艺/offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
【主营项目】
一.毕业证【q微741003700】成绩单、使馆认证、教育部认证、雅思托福成绩单、学生卡等！
二.真实使馆公证(即留学回国人员证明,不成功不收费)
三.真实教育部学历学位认证（教育部存档！教育部留服网站永久可查）
四.办理各国各大学文凭(一对一专业服务,可全程监控跟踪进度)
如果您处于以下几种情况：
◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
◇面对父母的压力，希望尽快拿到；
◇不清楚认证流程以及材料该如何准备；
◇回国时间很长，忘记办理；
◇回国马上就要找工作，办给用人单位看；
◇企事业单位必须要求办理的
◇需要报考公务员、购买免税车、落转户口
◇申请留学生创业基金
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
Addiction to Winning Across Diverse Populations.pdf
A anaysis dedicated to identify the addiction on winniing by diverse population
Ganpati Kumar Choudhary Indian Ethos PPT.pptx
Ganpati Kumar Choudhary Indian Ethos PPT.pptx, The Dilemma of Green Energy Corporation
Green Energy Corporation, a leading renewable energy company, faces a dilemma: balancing profitability and sustainability. Pressure to scale rapidly has led to ethical concerns, as the company's commitment to sustainable practices is tested by the need to satisfy shareholders and maintain a competitive edge.
12 steps to transform your organization into the agile org you deserve
During an organizational transformation, the shift is from the previous state to an improved one. In the realm of agility, I emphasize the significance of identifying polarities. This approach helps establish a clear understanding of your objectives. I have outlined 12 incremental actions to delineate your organizational strategy.
Public Speaking Tips to Help You Be A Strong Leader.pdf
In the realm of effective leadership, a multitude of skills come into play, but one stands out as both crucial and challenging: public speaking.
Public speaking transcends mere eloquence; it serves as the medium through which leaders articulate their vision, inspire action, and foster engagement. For leaders, refining public speaking skills is essential, elevating their ability to influence, persuade, and lead with resolute conviction. Here are some key tips to consider: https://joellandau.com/the-public-speaking-tips-to-help-you-be-a-stronger-leader/
Resource-mobilization-guide-for-community-based-organizations1.pdf
resource mobilization guidebook for comminute based organizations
20240608 QFM019 Engineering Leadership Reading List May 2024
Everything I found interesting about Engineering Leadership in May 2024
Sethurathnam Ravi: A Legacy in Finance and Leadership
Sethurathnam Ravi, also known as S Ravi, is a distinguished Chartered Accountant and former Chairman of the Bombay Stock Exchange (BSE). As the Founder and Managing Partner of Ravi Rajan & Co. LLP, he has made significant contributions to the fields of finance, banking, and corporate governance. His extensive career includes directorships in over 45 major organizations, including LIC, BHEL, and ONGC. With a passion for financial consulting and social issues, S Ravi continues to influence the industry and inspire future leaders.
Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...
Colby Hobson stands out as a dynamic leader in the residential construction industry. With a solid reputation built on his exceptional communication and presentation skills, Colby has proven himself to be an excellent team player, fostering a collaborative and efficient work environment.
Strategic Org Design with Org Topologies™
Org Design is a core skill to be mastered by management for any successful org change.
Org Topologies™ in its essence is a two-dimensional space with 16 distinctive boxes - atomic organizational archetypes. That space helps you to plot your current operating model by positioning individuals, departments, and teams on the map. This will give a profound understanding of the performance of your value-creating organizational ecosystem.
Risk-Management-presentation for cooperatives
Power point presentation for risk management for cooperatives
原版制作(CDU毕业证书)查尔斯达尔文大学毕业证PDF成绩单一模一样
学校原件一模一样【微信：741003700 】《(CDU毕业证书)查尔斯达尔文大学毕业证PDF成绩单》【微信：741003700 】学位证，留信认证（真实可查，永久存档）原件一模一样纸张工艺/offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
【主营项目】
一.毕业证【q微741003700】成绩单、使馆认证、教育部认证、雅思托福成绩单、学生卡等！
二.真实使馆公证(即留学回国人员证明,不成功不收费)
三.真实教育部学历学位认证（教育部存档！教育部留服网站永久可查）
四.办理各国各大学文凭(一对一专业服务,可全程监控跟踪进度)
如果您处于以下几种情况：
◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
◇面对父母的压力，希望尽快拿到；
◇不清楚认证流程以及材料该如何准备；
◇回国时间很长，忘记办理；
◇回国马上就要找工作，办给用人单位看；
◇企事业单位必须要求办理的
◇需要报考公务员、购买免税车、落转户口
◇申请留学生创业基金
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
Integrity in leadership builds trust by ensuring consistency between words an...
Integrity in leadership builds trust by ensuring consistency between words and actions, making leaders reliable and credible. It also ensures ethical decision-making, which fosters a positive organizational culture and promotes long-term success. #RamVChary
Make it or Break it - Insights for achieving Product-market fit .pdf
This presentation was used in talks in various startup and SMB events, focusing on achieving product-market fit by prioritizing customer needs over your solution. It stresses the importance of engaging with your target audience directly. It also provides techniques for interviewing customers, leveraging Jobs To Be Done for insights, and refining product positioning and features to drive customer adoption.
在线办理(UVic毕业证书)维多利亚大学毕业证录取通知书一模一样
学校原件一模一样【微信：741003700 】《(UVic毕业证书)维多利亚大学毕业证》【微信：741003700 】学位证，留信认证（真实可查，永久存档）原件一模一样纸张工艺/offer、雅思、外壳等材料/诚信可靠,可直接看成品样本，帮您解决无法毕业带来的各种难题！外壳，原版制作，诚信可靠，可直接看成品样本。行业标杆！精益求精，诚心合作，真诚制作！多年品质 ,按需精细制作，24小时接单,全套进口原装设备。十五年致力于帮助留学生解决难题，包您满意。
本公司拥有海外各大学样板无数，能完美还原。
1:1完美还原海外各大学毕业材料上的工艺：水印，阴影底纹，钢印LOGO烫金烫银，LOGO烫金烫银复合重叠。文字图案浮雕、激光镭射、紫外荧光、温感、复印防伪等防伪工艺。材料咨询办理、认证咨询办理请加学历顾问Q/微741003700
【主营项目】
一.毕业证【q微741003700】成绩单、使馆认证、教育部认证、雅思托福成绩单、学生卡等！
二.真实使馆公证(即留学回国人员证明,不成功不收费)
三.真实教育部学历学位认证（教育部存档！教育部留服网站永久可查）
四.办理各国各大学文凭(一对一专业服务,可全程监控跟踪进度)
如果您处于以下几种情况：
◇在校期间，因各种原因未能顺利毕业……拿不到官方毕业证【q/微741003700】
◇面对父母的压力，希望尽快拿到；
◇不清楚认证流程以及材料该如何准备；
◇回国时间很长，忘记办理；
◇回国马上就要找工作，办给用人单位看；
◇企事业单位必须要求办理的
◇需要报考公务员、购买免税车、落转户口
◇申请留学生创业基金
留信网认证的作用:
1:该专业认证可证明留学生真实身份
2:同时对留学生所学专业登记给予评定
3:国家专业人才认证中心颁发入库证书
4:这个认证书并且可以归档倒地方
5:凡事获得留信网入网的信息将会逐步更新到个人身份内，将在公安局网内查询个人身份证信息后，同步读取人才网入库信息
6:个人职称评审加20分
7:个人信誉贷款加10分
8:在国家人才网主办的国家网络招聘大会中纳入资料，供国家高端企业选择人才
Enriching engagement with ethical review processes
New ethics review processes at the University of Bath. Presented at the 8th World Conference on Research Integrity by Filipa Vance, Head of Research Governance and Compliance at the University of Bath. June 2024, Athens
Recently uploaded (20)
Comparing Stability and Sustainability in Agile Systems
Comparing Stability and Sustainability in Agile Systems
Employment Practices Regulation and Multinational Corporations
Employment Practices Regulation and Multinational Corporations
Addiction to Winning Across Diverse Populations.pdf
Addiction to Winning Across Diverse Populations.pdf
12 steps to transform your organization into the agile org you deserve
12 steps to transform your organization into the agile org you deserve
Leadership Ethics and Change, Purpose to Impact Plan
Leadership Ethics and Change, Purpose to Impact Plan
Public Speaking Tips to Help You Be A Strong Leader.pdf
Public Speaking Tips to Help You Be A Strong Leader.pdf
Resource-mobilization-guide-for-community-based-organizations1.pdf
Resource-mobilization-guide-for-community-based-organizations1.pdf
20240608 QFM019 Engineering Leadership Reading List May 2024
20240608 QFM019 Engineering Leadership Reading List May 2024
Sethurathnam Ravi: A Legacy in Finance and Leadership
Sethurathnam Ravi: A Legacy in Finance and Leadership
Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...
Colby Hobson: Residential Construction Leader Building a Solid Reputation Thr...
Integrity in leadership builds trust by ensuring consistency between words an...
Integrity in leadership builds trust by ensuring consistency between words an...
Make it or Break it - Insights for achieving Product-market fit .pdf
Make it or Break it - Insights for achieving Product-market fit .pdf
Enriching engagement with ethical review processes
Enriching engagement with ethical review processes
Reliance and Recognitions (GMP Inspections)
- 1. Cooperation is the Indispensible Strategy of Future 14 Jan 2018
- 2. Mutual
- 8. GMP Inspections and fast expanding Global Burden due to complex supply chain
- 16. Pure Consistent Zero Mix Up Drug Batches 1 2 3 Batch after Batch Within Batch Time after Time
- 17. GMP Elements Premises Equipment Personnel Materials Documentation Qualification & Validation Etc.
- 19. GMP System Indicators & Attributes Complaints Recall Investigations & CAPA Internal Audits Reviews Change Management Supplier Qualification Risk Management Deviations Master Maintenance Plan Master Validation Plan Master Training Plan Calibration
- 20. Best management of knowledge Fast information exchange Best management of resources Emerging burden & response time
- 21. Mutual Recognition Benefits More Practical to Oversee Greater Efficiency Strengthening Inspections
- 22. EU-FDA Mutual Recognition Agreement on GMP Inspections Started in 1998 Partial operation Rapid alert system Operational on 01 Nov 2017 In Operation Initially 8 EU member states recognized by FDA
- 23. 8 EU Member States Austria Croatia France Italy Malta Spain Sweden UK EU-FDA Mutual Recognition Agreement on GMP Inspections
- 24. No duplication of inspections by the respective authorities from 01 Nov 2017 Confidence building exercise done by both authorities to assess the capability, capacity and procedures in place to conduct GMP inspections EU-FDA Mutual Recognition Agreement on GMP Inspections