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03Aug
Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience
1:00 PM - 2:00 PM New York
Date: August 03, 2021 to August 03, 2021
Where: New York, New York,, New York County, New York, United States, 10000
Phone: N/A
Event Type: Other
Ticket Price: N/A
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
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