Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 20th Apr'24 to 30th Apr'24
Qualification and Control of Contract Manufacturer Organizations (CMO)
- Supplier Management Principles
- Supplier Quality Categories
- Approved Vendor List (AVL)
- Phases of Supplier and 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 supplier and CMO-key practical points
- Distinctive Technical Competence
- Optimum Supplier Size
- Risk of educating future competitor
- Key points for the contract
- Change approval by both supplier and company
- Quality Agreement
- Dealing with Uncooperative Suppliers
Overview of the webinar
Suppliers and CMOs must be selected following a rigorously 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.
Who should attend?
This webinar will provide valuable assistance to all personnel in:
- Purchasing
- Engineering
- Manufacturing
- Quality
- Regulatory
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 CMOs must be selected following a rigorously 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 CMOs in the medical device industry.
Faculty - Mr.Edwin Waldbusser
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 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.