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Podcast: Voices In Validation
Episode:

Effective Audits in the Medical Device Industry
Category: Science & Medicine
Duration: 00:48:00
Publish Date: 2020-12-22 15:00:52
Description:

This week, Stacey is joined once again by Alan Golden. On this episode Stacey and Alan talk about ways in which medical device companies can prepare for audits, know what to expect during the audit, and how they should respond to audit findings.

Alan Golden, MS, Principal Design Quality Consultants, LLC Alan Golden is Principal at Design Quality Consultants, LLC where he works with clients training and advising on topics in the medical device industry including Design Control, Change Control, Risk Management and process/test method validation. Alan has more than 30 years’ experience working in the medical device industry. In addition to his expertise in Design Controls, he is also highly experienced in Good Laboratory Practice (GLP), 21 CFR 820, ISO 13485, ISO 14971, Biotechnology, and U.S. Food and Drug Administration (FDA) and risk management. He retired from Abbott Molecular in 2018.

Links: CFR 21 - Part 806.10. - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=806.10 CFR 21 – Part 806.20 - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=806.20 ISO 13485:2016 - Medical device - QMS- Requirements for regulatory purposes - https://www.iso.org/standard/59752.html

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
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