Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

This seminar will help all personnel responsible for CMO oversight understand how to ensure effective quality oversight of CMOs- from start to finish. In-depth focus will be placed on Selection and Qualification, CMO Audits, Quality Agreements, Oversight of CMO Operations, and Review of Key CMO Records. Considerations for different types of manufacturing will be highlighted, and techniques for managing difficult CMO situations will be addressed. Techniques for assuring robust CMO Oversight programs in light of COVID-19 restrictions will also be discussed.

This is a practical how-to course, designed to provide participants with skills they can immediately apply to CMO oversight within their own organizations. Case studies will allow participants to practice skill sets in cooperation with the instructor.

Learning Objectives:

Upon completing this course, participants should be able to:

• Understand the CMO business model
• Understand the regulatory requirements for CMO quality oversight
• Understand how to structure your organization for effective CMO oversight
• Understand key points for selecting and qualifying CMOs
• Know how to prepare for and conduct CMO Audits
• Know how to develop a Quality Agreement and how to execute it
• Understand key points for reviewing CMO records
• Know how to resolve issues identified in CMO records
• Know how to manage CMOs on an ongoing basis

Who will Benefit:

This course is designed for people tasked with oversight of these CMO functions:

• Manufacturing operations
• Quality Control operations
• Quality Assurance operations

The following personnel will benefit from the course:

• Pharmaceutical Development
• Quality Control
• Validation
• Regulatory Affairs
• Quality Assurance
• Project Management