Supplier Management for Medical Device Manufacturers 2 Day Seminar

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,& High Tea/Coffee provided by WCS

Free Handouts for Attendees:

 • Two guidance documents referenced

 o GHTF Guidance document: Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers
 o NBOG Guidance document: Guidance for Notified Bodies auditing suppliers to medical device manufacturers

 • Example Approved Supplier list
 • Example Supplier evaluation form
 • 2 examples or Supplier QA Agreements

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 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).