CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract Drug Manufacture

This webinar will give a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting , also attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

Roger Cowan
Instructor:
Roger Cowan
Date:
Tuesday, June 18, 2020
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 503138

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Overview:

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.

Recently, the EU and the FDA issued regulatory guidance to bring some clarity and consistency to these quality contracts:

  • EU GMP Chapter 7 "Outsourced Activities" (Revised)
  • Draft Guidance for Industry - "Contract Manufacturing Arrangements for Drugs: Quality Agreements" May 2013

Why should you Attend: In 2010, the global CMO market was estimated at $26 billion dollars. Year on year growth has been 10.7% since 2008.

The increasing use of outsourcing in the pharmaceutical industry along with recent well publicized quality issues with CMOs, make it a necessity to have excellent quality oversight of external manufacturers to provide assurance of GMP compliance. A Quality Agreement is one tool used to accomplish this objective.

This Webinar presentation will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective.

Control of suppliers such as Contract Manufacturing Organizations has always been a requirement of the FDA and EU. With the issuance of these new regulatory documents; the expectation is that there will be a written documentation of this control.

Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO.

Each proposed section of a Quality Agreement is fully analyzed and suggested content is written with the new guidelines taken into consideration. Comparison of the two regulatory documents is presented with differences highlighted and discussed.

Detailed discussion of Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. is covered. The latest status of the FDA draft guidance is discussed and a review of comments from industry is included.

Areas Covered in the Session:
  • The Who and What of a good Quality Agreement
  • What a Quality Agreement is - and is not
  • Responsibilities of the owner vs. contract facility
  • GMP responsibilities
  • A comparison of the new guidelines from the FDA and the EU

Who Will Benefit:
  • Quality Assurance
  • External Manufacturing / Outsourcing
  • Quality Auditing
  • Technology Transfer
  • Regulatory Affairs / Compliance
  • Supply Chain
  • Purchasing
  • Risk Management


Speaker Profile
Roger Cowan is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. He has 37 years experience in pharmaceutical quality assurance and manufacturing. In his career, Roger has held various manager / director positions in Quality Assurance, QC Laboratory, Technical Services Validation, Manufacturing, and Clinical Supply manufacturing and distribution. Roger has taught courses in microbiology at Seneca College (Pharmaceutical Technology Program) in Toronto, Canada.

Roger's areas of expertise include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US / International regulatory requirements, regulatory submissions, and quality assurance/control.


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