Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

If you use CMOs, your firm is fully responsible for product quality, safety, efficacy, and cGMP compliance. Furthermore, FDA has clearly stated that firms using CMOs will be held accountable for CMO compliance to cGMPs, as well as for CMO adherence to Sponsor regulatory commitments. Issues identified at your CMO may result in FDA 483s and/or Warning Letters issued to your firm. Therefore, it is imperative that your organization have a robust CMO management system. At the end of the day, your ability to provide proper quality oversight of CMOs is the key to assuring product safety and safeguarding your firm’s compliance profile.

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.

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