Analytical Quality by Design (AQbD) is an emerging and important topic for the regulated industry as well as business organizations utilizing Analytical Development Research.
This seminar aims at bringing the concepts and benefits of the AQbD along key requirements of the program and specific similarities and differences between Pharmaceutical Quality by Design (QbD) and Analytical Quality by Design (AQbD) as well as the alignment between these two areas.
Current requirements and changes in the latest guidance for method validation will also be stipulated.
This workshop describes concepts, background and history of the Quality by Design and identifies requirements and content of the Analytical Quality by Design (AQbD) in application for analytical method development, validation and method life cycle management.
Additionally, the review of key requirements by the current ICH/FDA guidance for Industry: “Analytical Procedures and Methods Validation for Drugs and Biologics:” will be provided along with the examples and benefits of AQbD approach to method development, validation and life cycle management.
Who Should Attend?
This webinar is applicable to all Personnel, Scientists, Managers, program Directors and regulatory Officers involved in Analytical Method Development, Validation and Quality Management of Method Life Cycle.
Dr. Jerzy Zadykowicz is currently an Executive Director, R&D responsible for Analytical research and Development at Taro Pharmaceuticals Inc. Canada. Jerzy has over 20 years of experience in the regulated pharmaceutical R&D in various roles involving R&D development of sterile, solid dosage and semi-solid and liquid pharmaceutical products.
Jerzy has been involved in filing numerous regulatory submissions for analytical research CMC files in North American and International regulatory markets as well as in regulatory inspections and responses to.
Over the time of his career, he has been an active member of the industry and member of professional organizations including executive roles in the Chemical Institute of Canada as well as membership in Canadian Association of Pharmaceutical Scientists and American Association of Pharmaceutical Scientists and an active participant of topical semis-solid complex formulation chapters of AAPS. Jerzy is a mentor and collaborative leader who leads by example a large team of Analytical Scientists working within regulated pharmaceutical development of complex semi-solid pharmaceuticals.
In addition to his professional experience, Dr. Zadykowicz holds Master Degree in Organic Synthetic Chemistry from Warsaw University, Poland and Doctorate in Organic/Metal Organic and Coordination Chemistry from York University, Canada. His research work was published in number of well recognized journals and cited in numerous research publications.
|Student Ticket:||$100.00||— On Sale||Until: 15/11/19 11:55 PM|
|Basic Member Ticket:||$210.00||— On Sale||Until: 15/11/19 11:55 PM|
|Pro/Pro Plus Member Ticket:||$180.00||— On Sale||Until: 15/11/19 11:55 PM|