4th CMO Quality Oversight & Risk Management

In 2010 the global CMO market was valued at $26 billion experiencing year on year growth of 10.7% since 2008. Updated forecasts anticipate the market experiencing revenues around $60 billion by 2018. With this huge rise in outsourcing, coupled with major product recalls and quality manufacturing troubles in the Asian region, it has never been more critical to have robust quality oversight strategies to effectively oversee CMO partners and ensure GMP compliance.

ExL Pharma’s 4th CMO Quality Oversight & Risk Management Conference is the only opportunity to gain best practice strategies to effectively oversee and manage quality of external manufacturers. Gain vital updates on the revised FDA guidance for quality agreements, as well as an update on USP 432 elemental impurities limits and procedures. Hear from your quality and manufacturing counterparts about how quality systems are being aligned across multiple CMOs, how to identify potential quality failures among CMOs, metrics of lag to bring drugs to market more quickly and implementing operational excellence within harmonized systems.

TOP FIVE REASONS TO ATTEND

1. Get up-to-date on the newest FDA guidance: Contract Manufacturing Arrangements for Drugs: Quality Agreements to ensure quality agreements are robust and protective
2. Strategize on functional methods to overcome quality systems and IP challenges when working with manufacturers in China and India
3. Collaborate with multiple CMOs to ensure quality systems are synced and compliant
4. Leverage leading indicators to proactively identify if a CMO will have quality failures
5. Ensure strategic mechanisms are in place for methods and technology transfer

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Who Should Attend