Qualification of Contract Manufacturer Organizations Based on Practical Experience

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices"

Product quality and safety remains with the company

Description

This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs). It will teach best practices to meet regulatory requirements and satisfy practical needs to obtain the best CMO.

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 Contract Manufacturing Organization (CMO). 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 CMO’s in the medical device industry.

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

Who will Benefit

•      Engineering personnel
•      QA personnel
•      Software developers
•      Project managers
•      Regulatory affairs professionals
•      Global contract manufacturing transfer teams
•      Quality Control personnel
•      Research & Development
•      Regulatory Affairs Professionals
•      Validation
•      Those that use contract manufacturing and contract testing facilities
•      Microbiology Professionals
•      Project Managers

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel

 


Speaker Profile

Edwin Waldbusser

Edwin Waldbusser retired from industry after 20 years in management of development of medical device products and development of company Quality Systems. Products included 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.

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.

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