In a pharmaceutical contract manufacturing arrangement, sponsor companies are only as compliant as their vendors. When a violation occurs, the manufacturer is held responsible for the cGMP deficiency itself, while the sponsor is held responsible for its lack of vendor oversight. The bottom line is this: If your CMO fails to meet regulatory standards, you lose out on millions in profits and patent exclusivity. If you are a CMO, you are assured to never win business from that sponsor again.
This course will provide sponsor companies with the necessary tools to make an informed decision when qualifying a manufacturing vendor’s compliance with cGMP. Conversely, the session will provide CMOs with proven techniques to win sponsor business and exceed regulatory AND performance expectations.
During this 90-minute webinar, SPONSORS will learn:
- The top five vendor qualification mistakes – how sponsors can avoid them
- The vendor selection process – weeding out dead weight in advance of the real work
- Establishing timelines that quickly qualify vendors for cGMP compliance
VENDORS will learn:
- The top five mistakes CMOs make in the qualification process
- How to organize and prepare for a vendor audit – right the compliance ship!
- Forming lasting relationships with your sponsor and ensure repeat business
Discussion will also focus on:
- Steps to identify needed outsourced services and begin the qualification process
- Inter-departmental coordination to ensure that the outsourced services meet the identified need
- Vendor interactions and the selection process – keys to success
- On-site vendor assessments – make the most of your time on-premises
- Resolutions/corrective action for observations
- Essential documentation, such as paper questionnaires, quality agreements, and vendor qualification checklists
- Data tracking and requalification activities