CMO Supplier Quality Agreements - How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture

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• The latest status of the FDA draft guidance is discussed and a review of comments from industry is included.