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

Held March 26, 2009

It’s true that using third-party suppliers and contractors can save medical device manufacturers a lot of money.

But it’s also true that focusing on quality and not just on cost reduction is prudent.

It’s essential to establish efficient and rigorous supplier control and auditing programs to assure the quality of the products being used in the finished devices.

Having the proper procedures in place to evaluate and monitor third-party suppliers and contractors isn’t just a good idea … it’s necessary and can keep you from having to deal with serious FDA enforcement issues.

Recent actions by the FDA related to third-party suppliers and contractors 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

Make sure your company doesn’t make the same types of mistakes. Find out the proactive steps you can take to make certain your outsourced suppliers and contractors stay in compliance with FDA regulations!

Join us for this crucial 90-minute audio CD/Transcript 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.
Order now for 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 in which a devicemaker should have someone on site to monitor a supplier’s operations

Discover how to select and manage suppliers and stay in compliance with FDA regulations!

This audio CD/Transcript 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
Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Steven Niedelman is a senior consultant at Crowell & Moring, LLP, focusing on food and drug matters in the Health Care Group. 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.

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