URGENT PANDEMIC INFORMATION
COVID CANCELLED: Project Management in Human Resources, Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference, Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers, Cambridge MA, Feb 2-4, 2021
COVID CANCELLED: US Immigration Compliance Strategies, Boston MA, Feb 15-18, 2021
COVID CANCELLED: Project Management Training, Boston MA, Mar 3-5, 2021
COVID CANCELLED: Internal Audit, Fraud Risk Assessment Workshop, Boston MA, Mar 22-25, 2021
COVID CANCELLED: Agile / Scrum Training, Boston MA, Apr 12-14, 2021
COVID CANCELLED: Validation, Verification and Transfer of Analytical Methods, Boston MA, Apr 19-21, 2021
COVID CANCELLED: Computer System Validation - Reduce Costs and Avoid 483s, Boston MA, May 10-12, 2021
COVID CANCELLED: SharePoint Technology Conference, Boston MA, May 26-28, 2021
COVID CANCELLED: Employment Laws Certificate Program, Boston MA, Jun 7-9, 2021
Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .
TENTATIVE: 21 CFR Part 11 Compliance, Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance, Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation, Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021, Boston MA, Dec 7-9, 2021
Boston Professional Events List
Webinar Qualification of Contract Manufacturer Organizations
Link to Website
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.
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
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
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems.
(Contact us : 844-267-7299 | 954-947-5671
Don't wait. Register TODAY or Email US [email protected]
VIP Life Time Subscription to our Newsletters!