Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience

Live Webinar: Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience When: Thursday August 3, 2021 - 01:00 PM EST Duration: 60 Minutes.

Register Now for Live Virtual Webinar

Regulatory agencies require that companies carefully select suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated to the Contract Manufacturing Organization (CMO). CMO’s must be selected following a rigorous formalized procedure.
This webinar will describe a compliant program based on regulatory requirements and the author’s personal experience in qualifying over 40 CMO’s in the medical device industry.
Areas Covered in the Session :
CMO management principles
Approved Vendor List (AVL)
Supplier quality categories
Phases of CMO selection from initial telephone inquiry to quality survey to qualification audit
Planning a qualification audit-establishing evaluation team
Conducting a qualification audit-key points to evaluate
Decision factors for selecting a CMO-key practical points
Key points for the contract
Dealing with uncooperative suppliers