Medical Device Supplier Audits What a Former FDA Official Can Tell You About Third-Party Monitoring
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To stop supplier quality problems, medical device firms must pay close attention to essential details, including receipts, bills of lading, shipping addresses, lot numbers, the number of a supplier’s personnel versus the claimed output of the facility, and much more.
And above all, companies must establish efficient and rigorous supplier control and auditing programs to assure the quality of the products being used in the finished devices.
If you don’t, you might end up like Intercoustics, who, according to a warning letter posted on the FDA's website in April, ran afoul of supplier regulations when:
- Reports documented that two incoming shipments were rejected because materials did not meet specifications
- The company’s required nonconformity report forms were not completed for either of those shipments, and
- Purchasing records revealed that annual evaluations had not been conducted for three of their suppliers of critical components, a requirement of the company’s supplier procedure
Make sure your company doesn’t make the same types of mistakes. Learn the steps you can take now to make certain your outsourced suppliers and contractors stay in compliance with FDA regulations.
FDAnews has invited Steven Niedelman, former deputy associate commissioner for regulatory operations and chief operating officer overseeing the Office of Regulatory Affairs headquarters at FDA, to lead this critically important upcoming webinar: Medical Device Supplier Audits: What a Former FDA Official Can Tell You About Third-Party Monitoring.
Niedelman has seen more than his share of supplier quality problems, involving FDA actions related to third-party suppliers and contractors such as these:
- 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
- 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.
FDA insider 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 he’ll 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 in which a devicemaker should have someone on site to monitor a supplier’s operations
Like every FDAnews webinar, Medical Device Supplier Audits is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you’re at the office or telecommuting from your office-in-home.
Of course, Niedelman will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.
Everyone in your organization with a role in supplier audits deserves to take part in this event — and they can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.
Order 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.