COURSE DESCRIPTION

OVERVIEW

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.

LEARNING OBJECTIVES

During this 90-minute webinar, SPONSORS will learn:

1. The top five vendor qualification mistakes – how sponsors can avoid them
2. The vendor selection process – weeding out dead weight in advance of the real work
3. Establishing timelines that quickly qualify vendors for cGMP compliance

VENDORS will learn:

1. The top five mistakes CMOs make in the qualification process
2. How to organize and prepare for a vendor audit – right the compliance ship!
3. Forming lasting relationships with your sponsor and ensure repeat business

Discussion will also focus on:

1. Steps to identify needed outsourced services and begin the qualification process
2. Inter-departmental coordination to ensure that the outsourced services meet the identified need
3. Vendor interactions and the selection process – keys to success
4. On-site vendor assessments – make the most of your time on-premises
5. Resolutions/corrective action for observations
6. Essential documentation, such as paper questionnaires, quality agreements, and vendor qualification checklists
7. Data tracking and requalification activities