Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements
Website https://worldcomplianceseminars.com/upcoming_webinar |
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Category Management, Production, Quality Management /Assurance, Regulatory
Deadline: January 24, 2020 | Date: January 24, 2020
Venue/Country: Online Webinar, U.S.A
Updated: 2020-01-04 14:57:27 (GMT+9)
Call For Papers - CFP
Product reviews are often requested by regulatory investigators. Annual Product Reviews have been a requirement of the US GMPs for pharmaceutical products since 1978. More recently EU and Canada have included a requirement for Annual Product Quality Reviews in their regulations or guidances covering drug products.In this live training webinar we will discuss the world-wide regulatory requirements for Annual product Reviews (or Product Quality Reviews). Different geographic requirements for product review content will be discussed and evaluated.Session Highlights:• Requirements for Annual Product Reviews (Product Quality Reviews).• Annual Product Reviews and Annual Reports.• The Product Review as a tool in stage 3 of Process Validation- Continued process verification.• What should be included in the Annual Product Review.• Annual Product Review preparation.• Continuous improvement and the product review.• Management involvement in the Product review processSpeaker:John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of MichiganKeywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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