URGENT PANDEMIC INFORMATION

In light of the pandemic situation all of our 2021 events are cancelled. We will inform customers directly when the events are rescheduled.    
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
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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


Date
Jun 04, 2021 - 01:00 PM - Jun 05, 01:00 PM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  

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 Details


Speaker Profile

Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems.

Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]


Event Categories
Keywords: pharmaceutical




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