Live Webinar Qualification of contract manufacturer organizations based on practical experience

02:00 PM EDT | 09:00 AM PDT | 11:00 AM CDT Duration 60 Minute

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

"Hear By Charles H Paul has been a regulatory and management consultant and an Instructional Technologist for 30 years"

Attendees will receive “A 6 page Pre-Audit Questionnaire and a 25 page CMO audit form”

Description

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

Who will Benefit

---   Development Engineers
---   Production Management
---   QA/ QC personnel
---   Engineering management
---   Regulatory personnel

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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