DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs): One and a Half day In-Person Seminar" conference to their offering.
The globalization of the pharmaceutical supply chain has led increased use of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it can present unique compliance risks, particularly since the operations are not in your facility and therefore not under your direct control. The compliance risks are highlighted by FDA Warning Letter trends, the majority of which are related to serious compliance and data integrity issues at foreign CMO sites.
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.
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
Day 01 (8:00 AM - 4:30 PM)
- Registration Process: 8:30 AM - 9:00 AM
- Session Start Time: 9:00 AM
- The CMO Business Model
- What is CMO Oversight?
- Regulatory Requirements for CMO Oversight
- FDA Expectations and Warning Letters
- Structuring Your Organization for CMO Oversight
- CMO Selection and Qualification
- CMO Qualification Audits
- The Quality Agreement
Day 02 (9:00 AM - 1:00 PM)
- Getting to Know Your CMO
- Review of Key CMO Records
- Hot Topic- Data Integrity
- Routine CMO Audits
- Ongoing CMO Oversight
For more information about this conference visit http://www.researchandmarkets.com/research/jhcqxx/effective_quality