Why Should You Attend:
This webinar will help pharmaceutical, biological, and medical device personnel understand the objectives FDA has when doing inspections, the process FDA uses, and how the company can manage those FDA expectations. The roles of the various employees involved will be defined, the logistics, document management, plus front-room and backroom management.
Areas Covered in the Webinar:
Who Will Benefit:
Drug, biologic, and medical device 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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