Qualification and Control of Contract Manufacturers (CMO) Based on Practical Experience
Ed retired from industry after 27 years in management of development of medical device products and development of company Quality Systems. He has been a consultant for the last10 years, working with companies from startups to Fortune 100 in the US, Germany, United Kingdom, Netherlands, Canada, Poland, and Saudi Arabia. He specializes in design control, risk analysis, human factors, software validation, cybersecurity and supplier qualification/ control. Ed has a B.S. Mechanical Engineering from NYU and a 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.
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. The control of changes is one such topic that is complex. Lessons from practical experience show methods that will prevent a development program from becoming uncompliant.
- CMO management principles
- Supplier quality categories
- Approved Vendor List (AVL)
- Phases of CMO selection from initial telephone inquiry to a quality survey to qualification audit
- Planning a qualification audit-establishing evaluation team
- Conducting a qualification audit-key points to evaluate
- Decision factors for selecting 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.
Course Level - Basic to advanced
Who Should Attend
- Engineering management
- Quality Assurance
Why Should You Attend
Regulatory agencies require that companies carefully select and manage suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated to the CMO.
There are many practical concepts for selecting and managing CMO’s that are not found in the regulations that will be explained such as procedures for change control and criteria for selecting a CMO.