ComplianceOnline, Pyramid Club BNY Mellon Center Philadelphia, PA
2019-03-06
This seminar will help all personnel responsible for CMO oversight understand how to manage CMOs- from start to finish. In-depth focus will be placed on Selection and Qualification, Quality Agreements, Understanding 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 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. Group exercises will allow participants to practice skill sets with feedback from the instructor. Learning Objectives:Upon completing this course, participants should be able to: - Understand the CMO business model
- Learn the regulatory requirements for CMO quality oversight
- Learn how to structure your organization for effective CMO oversight
- Learn key points for selecting and qualifying CMOs
- Learn how to prepare for and conduct CMO Qualification Audits
- Learn how to develop a Quality Agreement and how to execute it
- Learn how to understand CMO operations
- Learn key points for reviewing CMO records
- Learn how to resolve issues identified in CMO records
- Learn how to prepare for and conduct routine CMO audits
- Learn 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
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Invited Speakers:
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Andrew Campbell has 25 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Mr. Campbell has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. He has extensive expertise in the areas of deviation - CAPA, change control, GMP auditing, GMP training, and regulatory inspection preparation and management. Working with large and small companies, Mr. Campbell has successfully developed, remediated and implemented key quality systems. He is a skilled GMP auditor, and has audited multiple API, drug product, packaging, testing, and distribution facilities. He is an experienced GMP trainer, and has developed customized and interactive training presentations for many companies. He has also provided FDA inspection support for several clients, including readiness training, on-site assistance during inspections, and authoring written responses to inspectional observations. Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as director of quality systems.
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