Managing GMP Complaints and Adverse Event Reports

Speaker

Instructor: Paul Larocque
Product ID: 706675
Training Level: Basic to Moderate

Location
  • Duration: 90 Min
This webinar addresses managing GMP Complaints and Adverse Event Reports related to drug products, biologicals, and medical devices. The relevant regulations will be discussed.
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Why Should You Attend:

You will learn about event capture, triage, investigation, and close out so as to meet FDA regulations and expectations.

Areas Covered in the Webinar:

  • Event capture and log in
  • Triage (seriousness)
  • Investigation; sample analyses
  • Records
  • Close out
  • Trend reports

Who Will Benefit:

Drug and biologic personnel working in production, R&D, regulatory affairs, QA, and QC.

Instructor Profile:
Paul Larocque

Paul Larocque
President, Acerna Inc

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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