Device Changes and the 510(k) Webinar
The FDA holds companies responsible for filing new 510(k) training when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes?
Why Should You Attend
The majority of medical devices are cleared for marketing in the U.S. by the FDA 510(k) process.
Areas Covered In This Webinar
What approaches are required for product changes; for process changes? How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?
U.S. FDA device clearance / approval
FDA´s and EU´s emphasis
Product changes and filing a new 510(k) clearance – who´s responsible
Tracking and evaluating changes – the "tipping point"
Is the process "risk based"?
K-97-1 and the FDA´s medical device approval
Documenting the process / rationale
Resolving wrong 510(k) submissions
Who Will Benefit
Senior Management, Project Leaders, Internal / External Consultants
Regulatory Affairs Personnel
Quality Systems Personnel
R&D and Engineering Staff
Personnel involved in Lean and Six Sigma Initiatives
John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years´ experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. 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. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.