San Francisco, California
London, United Kingdom
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.
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 fully 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
- Regulatory Affairs
- Quality Assurance
- Project Management
Note: Use coupon code < NB5SQH8N > and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.