Why Should You Attend:
FDA requires pharmaceutical, biological, and medical devices manufacturers to establish and maintain control over their suppliers to ensure the purchased goods or services meet Good Manufacturing Practices.
In this webinar, you will learn FDA’s expectations for the implementation and on-going operation of an effective vendor oversight program.
Areas Covered in the Webinar:
Frequently Asked Questions:
Who Will Benefit:
Pharmaceutical, biological, and medical device company personnel working in production, R&D, regulatory affairs, QA, and QC.Instructor Profile:
Paul Larocque is the President of Acerna Inc., a pharmaceutical, biological, and medical device consultancy, which provides good manufacturing practice and regulatory affairs services to a global clientele. For the past years consulting, and previously in industry, Paul’s focus was FDA compliance matters.
Previously, Paul held executive positions with Pfizer, Allergan, and Teva Pharmaceuticals, all related to sterile products. He was also head of the unit responsible for the review of the chemistry and manufacturing parts of drug submissions at Health Canada. He also chaired the industry committee that negotiated the sterile products chapter of the GMP regulations at Health Canada. He has provided expert sworn testimony in various legal cases.
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