Compliant Qualification of Contract Manufacturing Organizations (CMOs)

Description

Overview

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). However, CMOs must be selected following a rigorous formalized procedure.

This webinar by expert consultant, Edwin Waldbusser will discuss and explain how to operate a compliant program based on regulatory requirements while qualifying CMOs and contract software developers.

Handouts:

• 6 page pre-audit quality survey form
• 25 page CMO audit form

Session Highlights:

• 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 Will Benefit:

• Development engineers
• Production management
• QA/ QC personnel
• Software developers
• Engineering management
• Regulatory personnel
• Medical device industries