ContactUs:416-915-4458 Webinar On Webinar On Medical Device Changes and the 510(k) Presented By John E. Lincoln Tuesday, March 31, 2015 at 13:00 Hrs Hosting By Compliance Trainings Please visit us at https://compliancetrainings.com
ContactUs:416-915-4458 WeEmpower,YouComply! Webinar On Medical Device Changes and the 510(k) Product Id MD1541 Category Medical Devices Tuesday, March 31, 2015 at 13:00 Hrs Scheduled On Duration 90 Minutes Speaker John E. Lincoln Login at https://compliancetrainings.com/siteengine/Login.aspx WebinarDescription: This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k). Consideration of the U.S. FDA's current K-97-1 Memo / guidance document on "510(k) Device Modifications“ Control of medical device changes and a current 510(k) are big issues in recent FDA studies. Companies are held fully responsible for deciding when a new 510(k) filing is warranted. Often this is a difficult decision process. Effective change control and the power of current risk management tools must be a major part of such an analysis. The U.S. FDA has its current K-97-1 Memorandum (they recently pulled their proposed new draft Guidance Document, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device"). K97-1 provides a tool to assist in device and new 510(k) / change analysis. The addition of such simple tools will assist companies in implementing formal, documented, repeatable methods with defensible rationale for their decisions on when changes trigger the need for a new 510(k) submission.
The K97-1 analysis is the preferable tool to work with a company's change control system to document the need to file, or the rationale for not submitting a 510(k). It is recommended as the preferred method for documentation of each change in a device during its lifecycle. Provides for a Step-by-step analysis: Manufacturing, Labeling, Tech / Performance, and/or Materials Changes. Consideration of which of the three major 510(k) formats should be used: Traditional, Special or Abbreviated. Areas Covered in the Session : • This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's current Guidance on 510(k) Device Modifications. This session will cover: • Deciding When to Submit a 510(k) for a Change to an Existing Device, K97-1 • How to provide tools to document such decisions • It will discuss how companies can best document their decisions -- whether or not a new 510(k) filing is warranted • How to structure a decision matrix to document change decisions • How to evaluate changes that could trigger the "Tipping Point" • Who makes the decisions and how to defend them • How to implement formal methods with documented, and defensible rationale • Preparing for further 510(k) changes in the future Who will Benefit • This webinar is a must for companies in the Medical Device and combination products fields. The employees who will benefit include: • Research & Development • Engineering Staff • Quality Assurance
Regulatory Affairs • Lean & Six Sigma staff • New Product Development • Marketing • Mid-level and Senior Management • Project Leaders • Consultants Speaker Profile: 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 years as a full-time 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 has 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 ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.
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