Howard Cooper is a Keynote Speaker at Compliance Key Inc. 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 Quality and Regulatory Affairs functions.Howard's first experience in medical regulation was 1976 shortly after Congress passed the Medical Device Amendments of 1976 relating medical devices. He joined a medical device contractor with the responsibility to revamp the quality system to meet the new medical device GMP's and implement A Regulatory Affairs function. His next challenge was with a Fortune 500 company with the responsibility to revamp the medical materials quality system and to implement drug and pharmaceutical GMP's and for a new facility manufacturing medical products and transdermal drugs. This early experience demonstrates Howard's passion for Quality and Regulatory Affairs and how he constantly builds on his experience to build, manage, and remediate quality systems.
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 21....
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