This document discusses challenges in method validation from a regulatory laboratory perspective. It begins by defining validation and why it is important. Developing a validation procedure requires following accreditation standards and legislation. Harmonizing the validation approach has advantages like allowing results comparison. Key challenges include a lack of certified analytical standards, validating for multiple matrices, calculating measurement uncertainty, finding proficiency tests, ongoing verification, and determining what constitutes revalidation. The document promotes Eurachem resources on method validation and an upcoming Irish workshop on the topic.
This document discusses the impact horizon and indicators for assessing the impact of projects by the Generation Challenge Programme (GCP) as its funding ends in 2014. It outlines short, medium, and long term impact indicators and examples. Short term impacts include technical outputs like identified genes and markers. Medium term impacts involve breeding results like improved germplasm. Long term impacts are tangible yields from molecular breeding. The document emphasizes measuring acceleration of breeding through impact progression. It also discusses ensuring delivery of products and maintaining them post-delivery through cataloging, availability, and commitment.
This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning.
This document discusses quality agreements (QAGs) between clinical trial sponsors and vendors. It covers the basis and purpose of QAGs in clinical trials, considerations for the content of QAGs, and how to operationalize and use QAGs during regulatory inspections. Key points include that QAGs establish expectations between parties, important content areas cover quality control, auditing, and regulatory responsibilities, and QAGs can help demonstrate delegation of roles during inspections.
The document discusses documentation and standard operating procedures (SOPs) for GMP compliance. It describes issues found at a pharmaceutical company (Goran Pharma) regarding inadequate testing of glycerin lots for impurities. The FDA found the company's responses to be inadequate. The document also discusses how to properly write SOPs, including getting appropriate reviews and authorization. It provides examples of documentation issues found during an FDA inspection at another company (Lupin) regarding inadequate cleaning processes and validation. The FDA requested extensive corrective and preventative actions from Lupin to address their cleaning validation program and ensure proper documentation and process controls.
A study platform to generate brand specific influenza vaccine effectiveness: ...DRIVE research
DRIVE annual forum 2019, Helsinki, Finland, 17th-18th September
Development of Robust and Innovative Vaccine Effectiveness
Increasing understanding of influenza vaccine effectiveness in Europe
This document discusses challenges in method validation from a regulatory laboratory perspective. It begins by defining validation and why it is important. Developing a validation procedure requires following accreditation standards and legislation. Harmonizing the validation approach has advantages like allowing results comparison. Key challenges include a lack of certified analytical standards, validating for multiple matrices, calculating measurement uncertainty, finding proficiency tests, ongoing verification, and determining what constitutes revalidation. The document promotes Eurachem resources on method validation and an upcoming Irish workshop on the topic.
This document discusses the impact horizon and indicators for assessing the impact of projects by the Generation Challenge Programme (GCP) as its funding ends in 2014. It outlines short, medium, and long term impact indicators and examples. Short term impacts include technical outputs like identified genes and markers. Medium term impacts involve breeding results like improved germplasm. Long term impacts are tangible yields from molecular breeding. The document emphasizes measuring acceleration of breeding through impact progression. It also discusses ensuring delivery of products and maintaining them post-delivery through cataloging, availability, and commitment.
This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning.
This document discusses quality agreements (QAGs) between clinical trial sponsors and vendors. It covers the basis and purpose of QAGs in clinical trials, considerations for the content of QAGs, and how to operationalize and use QAGs during regulatory inspections. Key points include that QAGs establish expectations between parties, important content areas cover quality control, auditing, and regulatory responsibilities, and QAGs can help demonstrate delegation of roles during inspections.
The document discusses documentation and standard operating procedures (SOPs) for GMP compliance. It describes issues found at a pharmaceutical company (Goran Pharma) regarding inadequate testing of glycerin lots for impurities. The FDA found the company's responses to be inadequate. The document also discusses how to properly write SOPs, including getting appropriate reviews and authorization. It provides examples of documentation issues found during an FDA inspection at another company (Lupin) regarding inadequate cleaning processes and validation. The FDA requested extensive corrective and preventative actions from Lupin to address their cleaning validation program and ensure proper documentation and process controls.
A study platform to generate brand specific influenza vaccine effectiveness: ...DRIVE research
DRIVE annual forum 2019, Helsinki, Finland, 17th-18th September
Development of Robust and Innovative Vaccine Effectiveness
Increasing understanding of influenza vaccine effectiveness in Europe
Este documento define las diferentes generaciones de la web. La Web 1.0 se refiere al estado inicial de la World Wide Web y estaba diseñada principalmente para compartir información. La Web 2.0 promueve la información generada por los usuarios a través de herramientas que permiten una interacción más fácil. La Web 3.0 describe la interacción entre personas a través de diferentes formas como la transformación de la red. La Web 4.0 agrega opciones como acceso en línea a previsualizaciones y herramientas de análisis sin necesidad de instalación
The document discusses how the author attracted their audience in a film title sequence. To do so, the author included stereotypical horror elements like blood, gore and dead bodies. They also included elements of alcohol and mental instability to foreshadow events in the film and intrigue audiences. Scenes in the sequence show the protagonist in a park and her home, where dead bodies are discovered in various locations, leaving audiences wondering how many people she has killed and why. The sequence uses changes in time and location to further confuse audiences and make them want to continue watching to get answers.
Presentation by Katie Parks, Center for Towns Director, Eastern Shore Land Conservancy. Presented in an Ignite style during the 2016 MEDA Annual Conference
La factura de la luz detalla los cargos por el suministro de electricidad, incluyendo el término de potencia por la capacidad contratada, el impuesto eléctrico establecido por el gobierno, y el costo de la energía consumida según la tarifa. Además, la factura muestra datos como la dirección, periodo de facturación, potencia contratada, lecturas del contador, y otros detalles importantes sobre el consumo.
Rebecca E. Browning is an experienced attorney who has worked in private practice, as a county attorney, and as a parenting coordinator. She has experience litigating various legal matters including family law, juvenile dependency and severance, criminal law, and appellate cases. Browning is licensed in Arizona and the U.S. District Court of Arizona. She is involved in her local bar association and various community organizations focused on domestic violence, veterans, and disability rights.
Rakesh Rana has over 13 years of experience in project management, service delivery, and IT services. He has led projects for clients like P&G, Fiat Automobiles, and others. Rakesh is Prince2 and PMP certified with skills in project management, client management, planning, team building, and risk management. He currently works as a Project Manager at Accenture, managing digital content and websites for clients.
В нашей новой презентации вы узнаете о том, с каких уголков мира компания Coffee Roy's получает свой кофе, как часто мы занимаемся обжаркой. Также, сможете узнать наши расценки. Приятного просмотра!
This document outlines the agenda and logistics for a HOWEST Business Inspiration Tour to Tokyo, Japan. The tour will take place from February 4-10, 2017 and include visits to companies like Daikin and Canon, as well as cultural activities like touring the Tokyo Imperial Palace and Skytree Tower. Participants will stay at the Hilton Odaiba hotel and the price of €3900-4500 per person covers flights, transportation, meals, visits, and insurance. Interested participants can register online through the provided link.
Este documento explica cómo entender una factura de luz dividiéndola en diferentes secciones. La factura se divide en una parte azul con los datos del cliente, una parte amarilla con el consumo histórico y ofertas, y una parte rosa con detalles técnicos. Cada sección contiene conceptos como el nombre, NIF, número de contrato, consumo facturado, potencia contratada y fechas de lectura y vencimiento que ayudan a comprender los cargos en la factura. El objetivo es hacer que la factura sea más clara y
Este documento presenta 6 consejos para mejorar la experiencia con la herramienta de gestión de proyectos Asana. Los consejos incluyen usar campos personalizados para un mejor seguimiento de tareas, copiar tareas recurrentes para ahorrar tiempo, vincular tareas para un seguimiento más fácil, indicar dependencias entre tareas, encontrar tareas asignadas más rápido, y usar filtros avanzados para búsquedas complejas.
The document discusses the IC20 de-stratification fan, which draws warm air from ceilings and circulates it to lower levels. This creates a more even temperature and improves comfort while reducing energy costs by lowering the load on heating systems. The IC20 installs easily in suspended ceilings, is self-contained with no ducting needed, and is suitable for places like stores, auditoriums, and offices. It helps eliminate hot and cold spots to create a more comfortable environment and saves on heating and cooling costs.
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
Laboratory, medical and device performance and validation following regulator...GlobalCompliancePanel
Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead! Don't miss an opportunity to advance as a manager again!
Laboratory, Medical and Device Performance and Validation following Regulator...GlobalCompliancePanel
This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control.
Laboratory, medical and device performance and validation followingGlobalCompliancePanel
The document advertises a 2-day in-person seminar on June 15-16, 2017 in Salt Lake City, UT on laboratory, medical and device performance and validation following regulatory and ICH statistical guidelines. The seminar will be led by Dr. Al Bartolucci and will cover topics such as analytical methods validation, quality control, statistical process control, and risk management. The seminar costs $1,295 per delegate but early bird registration before June 13 saves $200. Group rates are available for multiple attendees.
Requirements for Establishing an Effective Cleaning Validation ProgramGlobalCompliancePanel
This 2 day course will cover practical guidance on cleaning validation
regulatory compliance, in conjunction with, risk-based, reasonable and
informed decision making and activity planning. This two day
interactive course will cover fundamental principles of a cleaning
validation program, exploring such concepts as the determination of
residues to be targeted, selection of analytical and sampling methods,
determination of appropriate limits in various pharmaceutical and
biotechnology processes, and establishment of scientific rationales
acceptable to regulatory inspectors.
Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manuf...GlobalCompliancePanel
The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications,
why FDA at my Facility is, and what do I do During an InspectionGlobalCompliancePanel
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.
This document provides information about an upcoming conference on electronic GMP systems. The conference will take place from March 18-20, 2015 in Prague, Czech Republic and will focus on the specification, implementation, and validation of electronic GMP systems. It will provide learning objectives on identifying the best systems, managing costs and risks, efficient implementation, and achieving promised benefits in a compliant manner. Experts will present on topics like new regulatory guidance, user requirements, project management, and ensuring data integrity. Attendees will participate in workshops to practice applying the concepts to real-world examples.
The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider.
Este documento define las diferentes generaciones de la web. La Web 1.0 se refiere al estado inicial de la World Wide Web y estaba diseñada principalmente para compartir información. La Web 2.0 promueve la información generada por los usuarios a través de herramientas que permiten una interacción más fácil. La Web 3.0 describe la interacción entre personas a través de diferentes formas como la transformación de la red. La Web 4.0 agrega opciones como acceso en línea a previsualizaciones y herramientas de análisis sin necesidad de instalación
The document discusses how the author attracted their audience in a film title sequence. To do so, the author included stereotypical horror elements like blood, gore and dead bodies. They also included elements of alcohol and mental instability to foreshadow events in the film and intrigue audiences. Scenes in the sequence show the protagonist in a park and her home, where dead bodies are discovered in various locations, leaving audiences wondering how many people she has killed and why. The sequence uses changes in time and location to further confuse audiences and make them want to continue watching to get answers.
Presentation by Katie Parks, Center for Towns Director, Eastern Shore Land Conservancy. Presented in an Ignite style during the 2016 MEDA Annual Conference
La factura de la luz detalla los cargos por el suministro de electricidad, incluyendo el término de potencia por la capacidad contratada, el impuesto eléctrico establecido por el gobierno, y el costo de la energía consumida según la tarifa. Además, la factura muestra datos como la dirección, periodo de facturación, potencia contratada, lecturas del contador, y otros detalles importantes sobre el consumo.
Rebecca E. Browning is an experienced attorney who has worked in private practice, as a county attorney, and as a parenting coordinator. She has experience litigating various legal matters including family law, juvenile dependency and severance, criminal law, and appellate cases. Browning is licensed in Arizona and the U.S. District Court of Arizona. She is involved in her local bar association and various community organizations focused on domestic violence, veterans, and disability rights.
Rakesh Rana has over 13 years of experience in project management, service delivery, and IT services. He has led projects for clients like P&G, Fiat Automobiles, and others. Rakesh is Prince2 and PMP certified with skills in project management, client management, planning, team building, and risk management. He currently works as a Project Manager at Accenture, managing digital content and websites for clients.
В нашей новой презентации вы узнаете о том, с каких уголков мира компания Coffee Roy's получает свой кофе, как часто мы занимаемся обжаркой. Также, сможете узнать наши расценки. Приятного просмотра!
This document outlines the agenda and logistics for a HOWEST Business Inspiration Tour to Tokyo, Japan. The tour will take place from February 4-10, 2017 and include visits to companies like Daikin and Canon, as well as cultural activities like touring the Tokyo Imperial Palace and Skytree Tower. Participants will stay at the Hilton Odaiba hotel and the price of €3900-4500 per person covers flights, transportation, meals, visits, and insurance. Interested participants can register online through the provided link.
Este documento explica cómo entender una factura de luz dividiéndola en diferentes secciones. La factura se divide en una parte azul con los datos del cliente, una parte amarilla con el consumo histórico y ofertas, y una parte rosa con detalles técnicos. Cada sección contiene conceptos como el nombre, NIF, número de contrato, consumo facturado, potencia contratada y fechas de lectura y vencimiento que ayudan a comprender los cargos en la factura. El objetivo es hacer que la factura sea más clara y
Este documento presenta 6 consejos para mejorar la experiencia con la herramienta de gestión de proyectos Asana. Los consejos incluyen usar campos personalizados para un mejor seguimiento de tareas, copiar tareas recurrentes para ahorrar tiempo, vincular tareas para un seguimiento más fácil, indicar dependencias entre tareas, encontrar tareas asignadas más rápido, y usar filtros avanzados para búsquedas complejas.
The document discusses the IC20 de-stratification fan, which draws warm air from ceilings and circulates it to lower levels. This creates a more even temperature and improves comfort while reducing energy costs by lowering the load on heating systems. The IC20 installs easily in suspended ceilings, is self-contained with no ducting needed, and is suitable for places like stores, auditoriums, and offices. It helps eliminate hot and cold spots to create a more comfortable environment and saves on heating and cooling costs.
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability.
Laboratory, medical and device performance and validation following regulator...GlobalCompliancePanel
Too often, we focus on getting things done and results and miss working on our self-development. Let's face it: this is how we get paid yet this is also how we keep falling behind when it comes to our careers. It's time to get ahead! Don't miss an opportunity to advance as a manager again!
Laboratory, Medical and Device Performance and Validation following Regulator...GlobalCompliancePanel
This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts one uses when investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and quality control.
Laboratory, medical and device performance and validation followingGlobalCompliancePanel
The document advertises a 2-day in-person seminar on June 15-16, 2017 in Salt Lake City, UT on laboratory, medical and device performance and validation following regulatory and ICH statistical guidelines. The seminar will be led by Dr. Al Bartolucci and will cover topics such as analytical methods validation, quality control, statistical process control, and risk management. The seminar costs $1,295 per delegate but early bird registration before June 13 saves $200. Group rates are available for multiple attendees.
Requirements for Establishing an Effective Cleaning Validation ProgramGlobalCompliancePanel
This 2 day course will cover practical guidance on cleaning validation
regulatory compliance, in conjunction with, risk-based, reasonable and
informed decision making and activity planning. This two day
interactive course will cover fundamental principles of a cleaning
validation program, exploring such concepts as the determination of
residues to be targeted, selection of analytical and sampling methods,
determination of appropriate limits in various pharmaceutical and
biotechnology processes, and establishment of scientific rationales
acceptable to regulatory inspectors.
Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manuf...GlobalCompliancePanel
The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:
The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs).
Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications,
why FDA at my Facility is, and what do I do During an InspectionGlobalCompliancePanel
Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.
This document provides information about an upcoming conference on electronic GMP systems. The conference will take place from March 18-20, 2015 in Prague, Czech Republic and will focus on the specification, implementation, and validation of electronic GMP systems. It will provide learning objectives on identifying the best systems, managing costs and risks, efficient implementation, and achieving promised benefits in a compliant manner. Experts will present on topics like new regulatory guidance, user requirements, project management, and ensuring data integrity. Attendees will participate in workshops to practice applying the concepts to real-world examples.
The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider.
In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production..
Applied statistics, with emphasis on verification, validation, and risk manag...GlobalCompliancePanel
The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows:
This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful market access. This includes
The Challenges of an Effective Change Control Program and How to Address OOS ...GlobalCompliancePanel
An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
the challenges of an effective change control program and how to address oos ...GlobalCompliancePanel
An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents.
In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production..
Implementing MDSAP (Medical Device Single Audit Program) for Compliance SuccessGlobalCompliancePanel
Reviewing the most significant changes affecting medical device standards and guidance documents, Understanding the MDSAP (goals and strategy), Analyzing the MDSAP main differences with standard auditing, Understanding grading of MDSAP non-conformances
This document provides information about a 2-day in-person seminar on medical device compliance titled "Compliance Boot Camp" to be held on March 23-24, 2017 in Washington, DC. The seminar will be led by Susanne Manz, an expert in quality, compliance, and Six Sigma for medical devices, and will cover topics such as quality system requirements, documentation best practices, auditing programs, and risk management. Attendees will receive a certificate of participation and access to the expert presenter. The regular price for one attendee is $1,295 but early bird registration saves $200. Group discounts are also available.
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Similar to Verification transfer-analytical-methods-switzerland (20)
Why should you attend:
Understand Verification and Validation, differences and how they work together
Develop a "Working Definition" of V&V, Qualification, and related terms
Discuss recent regulatory expectations
Software Verification & Validation requirements of the FDA and ISO.
The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies
Device and Manufacturing software requirements for V & V
How to determine & demonstrate an appropriate V & V strategy
How to determine & handle software for different Levels of Concern
What V&V is required for 3rd Party software-custom and Off-the-shelf
Impact of FDA, Mobile APPS, Cyber Security, and software standards such as IEC 62304
What to look for during software vendor audits.
V & V documentation and level of detail required for device submissions.
How to document a "risk-based" rationale, and use it in a resource-constrained environment
Determine key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points
New FDA FSMA Rules on the Sanitary Transportation of Human and Animal FoodsGlobalCompliancePanel
Transportation and Logistics food transportation food safety rules are currently being finalized by the U.S. Food and Drug Administration (FDA). Under congressional instructions, the Food Safety Modernization Act (FSMA) requires the FDA to establish rules to improve,
As defined by the Health Information Portability and Accountability Act (HIPAA), a Business Associate can be any organization or person working in association with or providing services to a Covered Entity who handles or discloses Protected Health Information (PHI) or Personal Health Records (PHR).
Registration
This document advertises a 2-day in-person seminar on statistical methods and data visualization techniques. It will be held on August 3rd-4th in Raleigh, NC and taught by James Wisnowski. Attendees will learn how to explore and communicate data visually using software like Excel, R, Tableau, and JMP. The seminar agenda covers topics like univariate and multivariate plots, interactive graphs, best practices in data visualization, and more. Early registration saves $200 off the $1,295 individual price. Group discounts are also available for multiple attendees.
EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines.
14 new fda fsma rules on the sanitary transportation of human and animal foodsGlobalCompliancePanel
This document summarizes a 2-day in-person seminar on the new FDA FSMA rules for sanitary transportation of food. The seminar will be held on August 17-18, 2017 in Raleigh, NC and cover topics such as definitions and responsibilities under the new rules, adulteration prevention, standards for management, sanitation and training, and how to develop a compliant transportation plan. Attendees will include food shippers, carriers, receivers, importers, handlers, logistics and food safety professionals. Discounts are available for multiple attendees registered together.
13 european regulatory procedures comprehensive overview of ema and national...GlobalCompliancePanel
EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines
The secret is - HIPAA Rules are easy and routine to follow - when they are explained step-by-step in plain language. In this seminar Paul Hales will capture your attention with visual presentations, discussion and learning exercises and show how to find the right rule with the step-by-step procedures you need when you need them.
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances.
As defined by the Health Information Portability and Accountability Act (HIPAA), a Business Associate can be any organization or person working in association with or providing services to a Covered Entity who handles or discloses Protected Health Information (PHI) or Personal Health Records (PHR).
When medical device companies consider Agile development methods, they often run into the key criticism that Agile groups produce little to no documentation, and that Agile stands in contradiction to the lifecycle standards outlined in IEC 62304.
An essential task in any compliance analytics workflow is to not only explore your data visually, but also to communicate your results professionally with graphic displays. Do you have the tools and skills to quickly and thoroughly perform these tasks?
What to expect in a federal hipaa audit & how to avoid auditGlobalCompliancePanel
I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you).
This course covers a very broad range of topics from worker classification, to employee classification, to establishing methods and rates of pay, what must be included in the rate of pay, hours that must be compensated as worked time, required benefits, de minimus working fringes,
If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. Statistics of course, requires constant practice.
Development of a safety program to save costs, delayed schedules and the human cost of injury or death. Safety management guidelines and techniques for the engineering, construction, and scientific professions. Includes costs of preparing the necessary safety documentation.
Modern hipaa compliance managing privacy, security, and breach notification...GlobalCompliancePanel
Day one sets the stage with an overview of the HIPAA regulations including HIPAA Breach Notification and the process that must be used to determine whether or not a breach is reportable, and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule.
This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016.
This document advertises a 2-day in-person seminar on incorporating risk management into HR policies taking place on July 27-28, 2017 in Philadelphia. The seminar, led by Ronald L. Adler, an HR consultant with over 40 years of experience, will cover topics such as conducting HR audits, assessing human capital risks, developing HR metrics, and the components of an HR audit model. Attendees will receive a participation certificate, seminar materials, and special access to future seminars and consulting services. Group discounts are available for multiple attendees.
HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance,
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
• Equipping health professionals to address questions, concerns and health misinformation
• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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Validation, Verification and Transfer of Analytical Methods
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alternative method instead of a compendial method, equivalency of
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Agenda:
Day One Day Two
2-day In-person Seminar:
Validation, Verification and Transfer of Analytical Methods
(Understanding and implementing guidelines from FDA/EMA, USP and ICH)
Lecture 1: Regulatory Background and Requirements
FDA and international requirements
The importance of ICH Q2 and USP chapters
USP approach for method validation:
New/revised Chapters 220, 1200, 1210, 1220,
1225
Learnings from the NEW FDA and WHO
method validation guidelines
Different requirements for GLP, GCP and GMP
The importance and steps of risk assessment
Exercise: Define risk numbers for different
methods
Lessons from recent FDA Warning Letters
Planning for cost-effective implementation
Lectures and Workshop Exercises
Lecture 2: Preparing Your Lab for Validation Studies
Analytical Instrument qualification
Part 11/Annex 11 compliance of computer
systems
Validation of chromatographic data systems
Validation and control of Excel spreadsheets
Qualification of reference standards and
materials
Lecture 3: Validation of Analytical Methods and Procedures
Developing a validation plan and SOP
ICH Q2 validation and test parameters:
Accuracy, precision, intermediate precision,
specificity, LOD, LOQ, linearity, range,
robustness, ruggedness
Examples for application specific acceptance
criteria
Examples for design and execution of test
experiments
Evaluation of test results: using statistical
models
Handling deviations from expected test results
Going through an example validation report
Lecture 4: Verification of Compendial Methods
FDA and equivalent international expectations
Scope and objectives of USP <1226>
USP <1226> verification requirements
Risk based approach for type and extent of
verification testing
Which validation parameters should be verified
Logical process to set acceptance criteria
Exercise: Application based verification testing
Lecture 1: Transfer of Analytical Methods and Procedures
The main objective of formal method transfer
Learnings from EU GMP Chapter 6 on method
transfer
USP <1224> : Choosing the approach for
transfer
Approach and benefits of comparative testing:
Developing a risk based test plan
Planning and developing an effective transfer
protocol
Preparing the receiving lab for the transfer
Method transfer to new technology:: HPLC to
UHPLC
Preparing the method transfer report
Exercise: Application specific comparative
testing
Lectures and Workshop Exercises
Lecture 2: Demonstrating Equivalency to Compendial
Methods
Method validation vs. equivalency testing
Definition, objective and scope of alternative
methods
Justification for the use of alternative methods
FDA and USP requirements
Options for alternatives to approved
procedures
Exercise: Equivalency testing - what and how
much
Documentation requirements
Lecture 3: Maintaining the Validated State
Monitoring method performance: system
suitability testing and quality control samples
Change control procedure for analytical
methods
Handling method changes vs. adjustments
Revalidation of analytical methods: when, what
to test
Method reviews as a cost effective alternative
to time based revalidation
Going through a review process
Regulatory reporting of post-approval changes
Examples for continuous improvements
Lecture 4: Special Applications and Validation Processes
Preview to the expected new USP general
chapter <1220> "The Analytical Procedure
Lifecycle”
Method development and validation using
Quality by Design principles following the new
FDA Guidance
Validation of bioanalytical methods according
to the FDA and EMA guidelines
Validation of stability indication method
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2-day In-person Seminar:
Validation, Verification and Transfer of Analytical Methods
(Understanding and implementing guidelines from FDA/EMA, USP and ICH)