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:
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!
Former FDA deputy associate commissioner for regulatory operations Steven Niedelman will 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 today to listen in and discover:
This audio CD/Transcript is a must for positions in the medical device industry, including:
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.
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