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Strategic Partner

June 1, 2017 - June 2, 2017

Supplier Management for Medical Device Manufacturers

Boston , Massachusetts

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Event Details

Begins: June 1, 2017

End: June 2, 2017

Event Location: Boston , Massachusetts

Website: https://worldcompl..etails/18

Event Organizer

Event Organizer: World Compliance Seminars Inc.

Contact Person:

Phone Number: 347-282-5400

Website: https://worldcomplianceseminars.com/

Overview

An Interative Workshop Presented BY WCS & Be Quality Associates LLC
Course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion  

Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate,
Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS

Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to device manufacturers, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment.
Building partnerships with your suppliers not only helps you meet FDA and ISO 13485 Notifed Body requirements, but can add value to your quality management system and your company.

Since FDA regulations do not allow FDA to audit your suppliers, unless that supplier makes finished medical devices, FDA requires that you have sufficient control over your suppliers. From time to time the FDA makes a reinterpretation of what this means. This is why the Good Manufacturing Practice (aka Quality System Regulations) is called cGMP. The “c” stands for current, meaning what the FDA considers the current state-of-the-art in the areas they regulate. This happened for supplier management within the last few years. So if you supplier management program has not been updated in the last few year, you might need to make major changes to it. In addition European Notified Bodies periodically update their expectations, and for suppliers this happened with the publication of a guidance document by the Notified Body Operations Group (NBOG).

This seminar will go into the details of the NBOG supplier guidance document and a GHTF (Global Harmonization Task Force) guidance that describes the current FDA expectation for supplier management.  
One of the major things introduced in these guidance document, is the concept of Risk, and the use of identified risks as part of the evaluation and monitoring of suppliers.  
This seminar will not only review requirements and expectation of the FDA and European Notified Bodies for supplier management, but will guide you on how to incorporate these into your supplier management process.    

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