Qualification of Contract Manufacturer Organizations Based on Practical Experience

"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 CMO"

Areas Covered in the Session:

• 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
• We will cover in detail CMO management principles
• Supplier quality categories
• Approved Vendor List (AVL)
• 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
• Distinctive technical competence
• Optimum CMO size
• Risk of educating future competitor
• Key points for the contract
• Change approval by both CMO and company
• Quality Agreement
• Dealing with uncooperative suppliersCMO’s must be selected following a rigorous formalized procedure

• Development Engineers
• Production Management
• QA/ QC Personnel
• Engineering Management
• Regulatory Personnel