Qualification of Contract Manufacturer Organizations Based on Practical Experience - Webinar

  • ID: 4382160
  • Webinar
  • 60 Minutes
  • World Compliance Seminar
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Attendees Will Receive a 6 Page Pre-Audit Questionnaire and a 25 Page CMO Audit Form

Personal experience in qualifying over 40 CMO’s in the medical device industry.

We will cover in detail 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

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 CMO.

Areas Covered:

  • 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
Note: Product cover images may vary from those shown
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  • Edwin Waldbusser Edwin Waldbusser ,
    Regulatory Consultant ,
    Med Device Advisors


    Ed retired from the 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. He is also owner of meddeviceadvisors which offers over 80 easy to customize medical device Quality System SOP's.

Note: Product cover images may vary from those shown
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This 60-minute online course is intended for professionals in the Medical Device, Biotechnology, and Pharmaceutical Industry. Although not presently stated in the draft, the same guide could be used by FDA Regulated Industries personnel.

  • Development Engineers
  • Production Management
  • QA/ QC personnel
  • Engineering management
  • Regulatory personnel
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown
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