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.
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.
For easy implementation, attendees will receive:
- 6 page CMO pre-audit quality survey form
- 25 page CMO audit survey form
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
Who Should Attend:
- Quality Assurance Departments
- Quality Control Departments
- Regulatory Affairs Departments
- Engineering Departments
- Research and Development Departments
- Validation Departments
- Project Managers
- Software Developers
- Global Contract Manufacturing Transfer Teams
- Those that use contract manufacturing and contract testing facilities
- Microbiology Professionals
Course Director: Edwin Waldbusser
Edwin Waldbusser 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, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He 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 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.