Medical Device Product Risk Management
Presented by John Lincoln, EAS Independent Consultant.
ISO 14971 (and ICH Q9) provide excellent starting points for developing a Product Risk Management Program and Files. This EAS webinar will provide valuable assistance to all regulated companies that need a repeatable methodology, and their in-house personnel trained in cGMP and MDR/CE-marking compliance. It will discuss and provide examples of ISO- and FDA/ICH-compliant product risk management templates, ISO 14971 and CGMP 21 CFR 820 (and ICH Q9 and 21 CFR 210/211) applying to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
About the Presenter
EAS Independent Consultant, John Lincoln, has worked with companies from start-ups to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. John has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, he has prior experience in military, government, electronics, and aerospace. John has published numerous articles in peer reviewed journals, book chapters, conducted workshops and webinars worldwide. He is a graduate of UCLA.