Qualification of Suppliers and Contract Manufacturing Organizations
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 CoveredSupplier management principlesSupplier quality categoriesApproved Vendor List (AVL)Phases of supplier and CMO selection from initial telephone inquiry to the quality survey to qualification auditPlanning a qualification audit-establishing evaluation teamConducting a qualification audit-key points to evaluateDecision factors for selecting a supplier and CMO-key practical pointsDistinctive technical competenceOptimum supplier sizeRisk of educating the future competitorKey points for the contractChange approval by both supplier and companyQuality AgreementDealing with uncooperative suppliersWhy Should You AttendRegulatory 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 AttendEngineering personnelQA personnelSoftware developersProject managersRegulatory affairs professionalsGlobal contract manufacturing transfer teams
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
