Description
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.
Why Should Attend?
- 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- The latest status of the FDA draft guidance is discussed and a review of comments from industry is included.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:
This webinar will provide valuable assistance to all personnel in:
- Quality Assurance
- External Manufacturing / Outsourcing
- Quality Auditing
- Technology Transfer
- Regulatory Affairs / Compliance
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