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Howard Cooper

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 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. 

Other examples
  • Developed the quality and regulatory affairs functions for a university incubator manufacturing brachytherapy devices and then taking it to commercialization
  • Planned, developed, and managed the startup and PAI approval of a combination API and finished pharmaceutical GMP facility
  • Joined the division of a Fortune 500 company under consent decree to completely develop and implement a new supplier and contractor qualification program as well as revamp the incoming material controls FDA and external consultants oversight
  • At the same time, he was a member of the official consent decree team working with the FDA and outside consultants 
  • He joined a major pharmaceutical company that had received a very damaging Form 483 and worked a on special teams to correct deficiencies. He was a co-leader on two teams.
As a consultant, he specializes in the following:
  • Developing and implementing GMP quality systems for Medical Devices, Pharmaceuticals And Biologicals, &
  • Diagnosing and remediating GMP quality systems
  • Responding to Form 483's and developing corrective action plans
  • Working on Consent Decrees
  • Diagnosing & remediating Supplier & Contractor Qualification and Control programs
  • Training and Lecturing on the FDA regulations.

 Webinar Id: LSHCHP001
 6 months unlimited
 Duration 60 mins
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Perspectives on Proactive Internal Auditing-for Compliance, Quality System Effectiveness and Product & Process Improvement

Senior Management has the responsibility to be involved in design and implementation of the quality system and this responsibility continues to include participation in quality activities. The most productive activity of this continued participation is to ensure that periodic internal audits are conducted to the term the effectiveness of the quality system established and that when deficiencies occur, solutions are effectively implement........

$167 Recorded (6 months unlimited access)
 Webinar Id: LSHCHC002
 6 months unlimited
 Duration 180 mins
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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

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 te........

$447 Recorded (6 months unlimited access)

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