Qualification and Management of CMOs (Contract Manufacturing Organizations)

Frank Carroll

Course description

Every pharmaceutical company hopes to obtain its desired expectations when it comes to important relationships with their outsourcing partners. This intensive course examines the root causes of critical issues that can arise within these relationships, which are much broader and deeper than the technical capability to perform a process.

This course examines the strategic and tactical outsourcing processes of selecting, monitoring, and managing an outsourced operation. It includes a review of domestic and international regulatory requirements and operational aspects including the role of the quality system. An in-depth discussion of risk-based supplier and material qualification processes, supplier selection, supplier monitoring, contracts/agreements, and auditing will be presented.

In addition, we will cover how best practices in project management can transform an outsourcing schedule into a true project plan. 

The live course includes hands-on workshops in which mini teams analyze case studies and present their findings.

Upon completion of this course, you will be able to:

• Implement effective methods to evaluate potential CMO’s and other critical suppliers
• Compare and contrast the multitude of regulatory requirements in outsourcing pharmaceutical operations
• Organize and implement an effective supplier/CMO qualification program based on risk management principles
• Implement project management “Best Practices” in outsourcing
• Recognize, determine the root cause, and improve common contractor/client relationship conflicts
• Apply Risk Management techniques to identify, prioritize, avoid and mitigate contractor risks