Medical Device Supplier Audits What a Former FDA Official Can Tell You About Third-Party Monitoring

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From raw materials to the finished product and everything in between, device manufacturers are outsourcing the development of their products more and more.

And when there’s a problem, the FDA doesn’t care which supplier is at fault, it’s only concerned with the company whose name appears on the product ... you!

And it’s common knowledge that the FDA is watching much more closely! Recent enforcement actions by the FDA related to outsourced suppliers include:

  • A $2.2 million fine against Advanced Bionic and its president for cGMP violations, including not notifying the agency of a vendor change and not sufficiently evaluating the new vendor
  • Several warning letters to Stryker, resulting in its announcement of an overhaul of its GMP compliance program, including increasing third-party monitoring, which is expected to cost tens of millions of dollars
  • A warning letter issued to Retro-Tech for not requiring an evaluation of potential suppliers, not requiring contractors to notify it of changes in their products or services, and not maintaining a list of documents describing product requirements, specifications and quality expectations
  • A citation issued to HoMedics for not having written agreements with three of its contract manufacturers to indicate who has authority for lot release and distribution

Yet a surprising number of device firms have little or no protocol in place to evaluate or monitor these outside suppliers.

Make sure your company doesn’t make the same mistake!

Join us for this crucial 90-minute Encore presentation and let former FDA deputy associate commissioner for regulatory operations Steven Niedelman walk you, step by step, through the FDA’s regulations for overseeing suppliers. He’ll detail the principal ways to evaluate, audit and select potential contractors who will adhere to your compliance standards. And Steven will provide practical advice on what to include in a contract that will protect you when a supplier-related issue arises.

Sign up your entire team to listen in and discover:

  • Five different ways to assess suppliers based upon risk
  • What types of audits and other documentation to require from potential suppliers
  • How to write solid contractual agreements and change control procedures that protect you from potential supplier problems
  • How the FDA sees the link between you and your supplier — what are your actual responsibilities?
  • How sister manufacturing facilities and subsidiaries can be considered by the FDA as contractors
  • Situations where a devicemaker should have someone on site to monitor a supplier’s operations

Register now and discover how to select and manage suppliers and stay in compliance with FDA regulations! Plus, you’ll get an opportunity to ask your toughest questions during the Q&A session.

This presentation is a must for positions in the medical device industry, including:

  • Compliance officers
  • General/corporate counsel
  • Manufacturing directors and supervisors
  • Purchasing
  • Packing and labeling
  • Regulatory/legislative affairs professionals
  • Operations
  • Plant engineering
  • Laboratory quality control
  • QA/QC

Currently, Steven Niedelman is a regulatory consultant providing executive-level consulting to medical device manufacturers and suppliers. Previously, he was an executive vice president at Quintiles Consulting, where he directed and oversaw the operations and the services it provided to assure client needs were met. He provided strategic advice and insight to the executive management of companies involved in, or facing FDA enforcement actions — from Form 483s to consent decrees. Prior to that, Steven worked for the FDA for 34 years, where most recently he served as the deputy associate commissioner for Regulatory Operations and chief operating officer overseeing the Office of Regulatory Affairs headquarters.

Register now!

Date: Sept. 8–26, 2008
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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