The globalization of the pharmaceutical supply chain has resulted in the increased use of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it also presents unique compliance risks, particularly since operations are not under your direct control. Compliance risks are highlighted by FDA Warning Letter trends, the majority of which are related to serious cGMP compliance and data integrity issues at foreign CMO sites.
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