Overview

FDA QMSR requires that medical device companies carefully select suppliers and contract manufacturers. The responsibility for product quality and safety remains with the company. It cannot be delegated. Suppliers must be selected following a rigorous risk based formalized selection procedure. 

Why should you Attend

This webinar will first describe the FDA QMSR and its requirements that apply to supplier selection. Then we will discuss a QMSR compliant program for supplier selection based on the author’s experience in qualifying over 40 suppliers and CMO’s. We will explain the process from an initial informal telephone contact to the qualification audit. Decision factors, such as supplier size, will be discussed. Quality Agreements will be discussed. Management, according to the QMSR, must be involved in the process. We will discuss management responsibilities.

Areas Covered in the Session

• QMSR description
  
• QMSR requirements applicable to supplier selection
  
• Management responsabilités
  
• Supplier quality categories
  
• Approved Vendor List (AVL)
  
• Phases of selection from initial telephone inquiry to quality survey to qualification audit
  
• Planning a qualification audit and establishing an evaluation team
  
• Conducting a qualification audit-key points to evaluate
  
• Decision factors for selecting a supplier-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

Who Will Benefit

• Systems development engineers
  
• QA/ QC
  
• Lab Managers and Analysts
  
• Production Managers
  
• Engineering managers
  

Speaker Profile