Qualification of Contract Manufacturer Organizations Based on Practical Experience
Duration: 60 Minutes
flat 40% off on this webinar use promo code
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.
11/01/2018 10:00 AMTraining Topic: Qualification of Contract Manufacturer Organizations Based on Practical ExperienceInstructor: Edwin Waldbusser
Objectives of the Presentation
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
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 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.
Who will Benefit
Regulatory affairs professionals
Global contract manufacturing transfer teams
Quality Control personnel
Research & Development
Regulatory Affairs Professionals
Those that use contract manufacturing and contract testing facilities
Your webinar shared successfully!
Get upto 30% off on all Live Webinars
Flat 50% off on all On-Demand Webinars and Package Training Programs. Learn Smarter Be a Pro.