Moving from the GMPs to the Pharmaceutical Quality System
- Speaker:John Lanese
- Product Code:GRC-90372
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Since the turn of the century, the FDA has been promoting the idea of a Pharmaceutical Quality System. This is supported by an FDA Guidance Document: Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations and ICH Q10; the Pharmaceutical Quality System. It is clear from FDA Form 483, Report of Observations given to pharmaceutical manufacturers and Warning Letters that the FDA is interpreting the GMPs (21CFR211) consistent with concepts found in ICH Q10; The Pharmaceutical Quality System. In this audio seminar we will discuss the systems that a firm must implement to be compliant with the CGMPs which is actually an implementation of the Pharmaceutical Quality System.
This live webinar will cover:
- The migration to Quality Systems
- ICH Q8, ICH Q9, ICH Q10, the Quality Metrics Guidance and the Process Validation guidance
- The interrelationship of the Quality System related guidance
- Implementation of the Quality System concepts into programs that support a contemporary interpretation of the GMPs
- The impact of Quality Metrics
- ICH Q10; The Pharmaceutical Quality System and how it impacts compliance to the CGMPs?
- The elements of ICH Q10 and how they relate to the GMPs.
- The ICH Q10 enablers and the challenge of Knowledge Management
- The impact of ICH Q8; Pharmaceutical Development, ICH Q9; Quality Risk Management and the 2011 FDA Guidance on Process Validation
- Recent FDA observations that demonstrate transition to the Pharmaceutical Quality System
- The use of the lifecycle concept in FDA guidance including the Process Validation Guidance and a USP stimuli article
Who should attend:
- Senior management – CEO, VPs
- Middle management - Directors, Managers
- Quality personnel – all levels
- Operations personnel – all levels
John G. (Jerry) Lanese is an independent consultant with a focus on Laboratory Controls, Quality Systems and the components of an effective Quality System as they apply to the pharmaceutical and medical device industries and their suppliers to those industries. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan. Dr. Lanese focuses on the development of Quality Systems and trains extensively on related topics. He lectures throughout the world and presents training in all formats (lectures, seminars and webinars) on a variety of topics related to Quality Systems, GMPs, APIs, training, laboratory operations, calibration, change control, deviations and product reviews for clients and seminar, webinar and conference providers.
Jerry is a member of the Editorial Board of the Journal of GXP Compliance and co-edits a continuing column, “GXP Talk” in the Journal of GXP Compliance.