Course Description:
This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. Some of the key aspects of the seminar include:
Learning how to apply QbD concepts to analytical methods
Discussing the types of methods required for different drug products
Understanding the types of impurities which must be addressed for drug products
Discovering how a lifecycle approach can link method development, validation, verification and transfer
Learning how ATP (Analytical Target Profile) can drive the lifecycle approach
Determining the importance of linking method uncertainty to specifications
Using a method feedback loop to facilitate method improvement
This approach will be linked with current compendial requirements. There will be opportunities for questions and interaction throughout the course as well.
Gregory Martin
Gregory P. Martin is president of Complectors Consulting which provides consulting and training in the area of pharmaceutical analytical chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry and was director of pharmaceutical analytical chemistry (R&D) for a major pharma company for a number of years. In addition, he has volunteered for the USP (U.S. Pharmacopeial Convention) for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee. He also serves on expert panels on validation and verification, weights and balances, residual solvents and use of enzymes for dissolution testing of gelatin capsules.
He has particular interest in QbD/lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. He is also past chair of the AAPS in vitro release and dissolution testing focus group. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.
ComplianceOnline
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.
Note: Use coupon code 232082 and get 10% off on registration.
This highly interactive course is designed to provide participants with a lifecycle approach to developing and validating analytical methods, including elements aligned with QbD concepts. Some of the key aspects of the seminar include:
Learning how to apply QbD concepts to analytical methods
Discussing the types of methods required for different drug products
Understanding the types of impurities which must be addressed for drug products
Discovering how a lifecycle approach can link method development, validation, verification and transfer
Learning how ATP (Analytical Target Profile) can drive the lifecycle approach
Determining the importance of linking method uncertainty to specifications
Using a method feedback loop to facilitate method improvement
This approach will be linked with current compendial requirements. There will be opportunities for questions and interaction throughout the course as well.
Gregory Martin
Gregory P. Martin is president of Complectors Consulting which provides consulting and training in the area of pharmaceutical analytical chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry and was director of pharmaceutical analytical chemistry (R&D) for a major pharma company for a number of years. In addition, he has volunteered for the USP (U.S. Pharmacopeial Convention) for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee. He also serves on expert panels on validation and verification, weights and balances, residual solvents and use of enzymes for dissolution testing of gelatin capsules.
He has particular interest in QbD/lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. He is also past chair of the AAPS in vitro release and dissolution testing focus group. Mr. Martin is author of several papers in the areas of dissolution and analytical method validation.
ComplianceOnline
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.
Note: Use coupon code 232082 and get 10% off on registration.
