online seminar 2019 - Webinar Qualification of Contract Manufacturer Organizations Based on Practical Experience

Overview
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.
Session Highlights
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
Speaker
Ed retired from 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.