FDA's New Guideline regarding Contract Manufacturing Arrangements for Drugs: QUALITY AGREEMENTS

Duration: 60 Minutes
This presentation outlines the contents of the FDA's Industry Guidance draft document titled Contract Manufacturing Arrangements for Drugs: Quality Agreements issued in May of 2013. While this was issued as a draft document, we know that while there may be some changes in wording, this Guidance Document is notification of FDA thinking and will be enforced as a cGMP document.
Contract Manufacturing
Instructor: Dr. James R Harris
Product ID: 500111
This guidance defines a Quality Agreement, what it should contain and responsibilities of both the product owner and the contract manufacturer. This is information that is critically important to all pharmaceutical manufacturers.

Who can Benefit:
This webinar will provide valuable assistance to all personnel in:
  • Personnel interested in exploring the fields of pharmaceutical manufacturing
  • New pharmaceutical manufacturing and quality supervisors and managers
  • Administrative managers in charge of pharmaceutical manufacturing or quality
  • Pharmaceutical manufacturing and quality Associates and Manager
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Instructor Profile:
Dr. Harris has over 25 years of senior level pharmaceutical industry experience. Following this and for the past 15 years, he operated a global consulting firm that provided guidance to firms in over 60 countries around the world. During his tenure in the pharmaceutical industry, he was very active in industry groups. He served on the PMA's Validation Advisory Committee and was chairman of the Computerized Systems Advisory committee where he wrote the original guideline on computer validation and negotiated its acceptance with FDA. While consulting, he and his consulting teams have assisted numerous clients around the world with validation of their manufacturing processes. Dr. Harris played a vital role in establishing many of the regulations in existence today, with particular emphasis on validation of all types.
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