Vendor Qualification and Compliance: What Sponsors & CMOs Must Know
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 live, 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
Who Should Attend:
This course is designed for anyone interested in improving their vendor qualification process – from either the sponsor or vendor side. Those in quality assurance, business development, purchasing, research and development, and project management will find this course especially useful.
Your Expert Instructor:
Rosanne Sylvia-Heeter is the Director of cGMP Compliance at Polaris Compliance Consultants, Inc. and has over 30 years of GMP, GLP, and GCP quality assurance and compliance experience with Active Pharmaceutical Ingredients (APIs), clinical research materials, and finished product. During her career, she has developed global quality systems and prepared both domestic and international facilities for FDA pre-approval inspections. Ms. Sylvia-Heeter has interacted with the FDA at both the headquarters and district levels. She has held positions as compliance manager, quality assurance manager, and global director at major research-based and generic pharmaceutical companies and consulting firms. She is a member of American Society of Quality, Regulatory Affairs Professional Society, and the North Carolina Regulatory Affairs Forum. Ms. Sylvia-Heeter holds a BS in Biology from Loyola University.