Qualification of contract manufacturer organizations based on practical experience
- Speaker:Edwin Waldbusser
- Product Code:GRC-90294
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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 CMO
Description of the topic:
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
Areas Covered in the Session:
- 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 suppliers
- 6 page Pre-Audit Quality Survey form.
- 25 page CMO audit form
Who will benefit:
- Development Engineers
- Production Management
- QA/ QC personnel
- Software developers
- Engineering management
- Regulatory personnel
- Medical Device Industries
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting internationally in the areas of design control, risk analysis and software validation for the past 9 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.