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    Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements

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    Website | Edit Freely

    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 process


    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 Michigan

    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.