Qualification of Suppliers and Contract Manufacturing Organizations
Ed retired from the industry after 30 years in management of the 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, software validation, and supplier qualification/ control. He has been consulting for the last 9 years now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. Ed has a B.S. Mechanical Engineering from NYU and an M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents. He is also an owner of www.meddeviceadvisors.com which offers over 80 easy to customize medical device Quality System SOP's.
Suppliers and CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements. Phases of supplier and CMO selection from initial telephone inquiry to the quality survey to qualification audit will be explained. The qualification audit will be described with key points to evaluate explained. How to deal with uncooperative suppliers will be explained.
Areas Covered
- Supplier management principles
- Supplier quality categories
- Approved Vendor List (AVL)
- Phases of supplier and CMO selection from initial telephone inquiry to the 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 supplier and CMO-key practical points
- Distinctive technical competence
- Optimum supplier size
- Risk of educating the future competitor
- Key points for the contract
- Change approval by both supplier and company
- Quality Agreement
- Dealing with uncooperative suppliers
Why Should You Attend
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 supplier or CMO. Suppliers and 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 suppliers and CMO’s in the medical device industry.
Who Should Attend
- Engineering personnel
- QA personnel
- Software developers
- Project managers
- Regulatory affairs professionals
- Global contract manufacturing transfer teams
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$200.00
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