Compliant Qualification of Contract Manufacturing Organizations (CMOs)

Product Id : FDA154
Instructor : Edwin Waldbusser
May 29, 2019 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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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
Speaker Profile:

Edwin Waldbusser is a Regulatory Consultant at Medical Device Advisors. He is holder of BSc. Mechanical Engineering and Master in Business Administration.

After more than 20 year of work and retirement from management of medical devices development (5 patents), Mr. Waldbusser is now a highly experienced consultant. He has been a consultant in the fields of risk analysis, software validation and design control for 8 years now.

Mr. Waldbusser is a Lloyds of London ISO 9000 Lead Auditor. He is also a board member of Thomson Reuter Expert Witness network.


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