Qualification and Control of Contract Manufacturer Organizations Based on Practical Experience
Duration : 60 Minutes
Edwin Waldbusser, Medical Device
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, softwa Read more
This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs). It will teach best practices to meet regulatory requirements and satisfy practical needs to obtain the best CMO.
Complimentary Hand-outs:
For easy implementation, attendees will receive:
- 6 page CMO pre-audit quality survey form
- 25 page CMO audit survey form
Course Objectives:
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.
Course Outline:
• 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
o Distinctive technical competence
o Optimum CMO size
o Risk of educating future competitor
• Key points for the contract
• Change approval by both CMO and company
• Quality Agreement
• Dealing with uncooperative suppliers
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Bonus**
For easy implementation, attendees will receive:
• 6 page CMO pre-audit quality survey form
• 25 page CMO audit survey form
Who Will Benefit:
• Engineering personnel
• QA personnel
• Software developers
• Project managers
• Regulatory affairs professionals
• Global contract manufacturing transfer teams
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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