This training program will provide regulatory requirements (US) of 21 CFR Section 820.30 (Design Control) and 820.180 (Records) for the medical device industry, ISO 13485 7.3, and the new EU MDR (replacing the MDD). We will illustrate the same with examples. It will furnish details on what each element should address, how and why.
Why Should You Attend?
One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical FiIe or Design Dossier under the old EU MDD, and the Technical Documentation requirements of the new EU MDR. Currently they serve different purposes, but there are similarities. Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.
The webinar includes a challenges and conclusion session as well.
Areas Covered in the Webinar:
Who Will Benefit:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up 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. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA