Live webinar Qualification of contract manufacture organizations (cmo)-a risk based approach

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 60 Minute

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 60 Min Live Webinar

"Hear By Edwin Waldbusser is a consultant retired from industry after 30 years in management of development of medical devices (5 patents). "

CMO management principles

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.

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.
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.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

• Development Engineers

• Production Management

• QA/ QC personnel

• Engineering management

• Regulatory personnel

• Software developers

• Project managers

• Global contract manufacturing transfer teams

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 30 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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