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