3-hr Virtual Seminar on An overview of the pharmaceutical manufacturing cycle: ICH Q7A, GMP for pharmaceutical active ingredients (PAI) and Part 210-211 Current Good Manufacturing Practices for Finished Pharmaceuticals

Howard Cooper is a Keynote Speaker at ComplianceKey. with over 40 years of experience in Pharmaceutical and Medical Device Quality in startup, small, medium, and large businesses and corporations This experience includes all levels of quality and regulatory affairs.  Howard began his quality experience at Anheuser-Busch in a Quality Management Training Program that introduced him to FDA regulation as well as to modern state-of-the-art proactive QA systems. This QA system strongly influenced his quality philosophy vision for starting up, developing, implementing, managing, and remediating Quali........


This webinar focuses on the GMP quality system of the drug manufacturing cycle beginning with ICH Q7A, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients then focusing on 21 CFR Part 210-211 Current Good Manufacturing Practices for Finished Pharmaceuticals. As you are aware, the very detailed Part 210-211 GMP is the gold standard for GMP quality systems. ICH Q7A is a very good example because the structure and terminology mimics Part 210 211. ICH Q7A, with its quality systems approach is more effective achieving quality objectives while Part 210-211 is more effective achieving compliance objectives. While the forces of compliance and quality require balance, it must tilt toward quality because quality focuses on meeting customer requirements. Compliance focuses on documentation that is important for recording events and establishing responsibility. Quality directs activities in the direction of fitness for use that fulfills and intended need.
This webinar will begin by comparing the differences between Part 210-211 and ICH Q7A and the principles they advocate. Then, the manufacturing cycle will be followed through each step of the process. Each key step in the process will be evaluated according to each GMP. observing the differences and similarities between them. 
Finally, this webinar will summarize the major strengths and weaknesses between the quality systems discussing the potential of a hybrid quality system encompassing the manufacture of both API and finished pharmaceutical the continuity. The pros and cons will be discussed. 
hybrid quality system could definitely provide a truly quality systems approach to GMP through combining or interchanging key quality principles.
This webinar will make considerable use of graphics such as flowcharts throughout the discussion.

Why should you attend this webinar?

Over the past decade, the FDA has prioritized change from compliance to a quality systems approach. The last major revision of Part 210-211 was in 1978 at which time the first Part 820 medical device GMPs were promulgated. This first medical device GMP incorporated both risk and quality systems approach and has had two major revisions resulting in a quality systems approach while balancing compliance needs 

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Webinar Id: LSHCHC002

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Duration: 180 mins

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