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Webinar Medical Device Changes and the 510(k)

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"

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Webinar Medical Device Changes and the 510(k)

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  1. 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

  2. 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 The U.S. FDA has its current K-97-1 Memorandum (they recently pulled their proposed new draft Guidance Document, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device").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.

  3. 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

  4. 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.

  5. To Register This Webinar Please Visit https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1541 Contact Us For Immediate Assistance At 416-915-4458 or Mail Us At uttam@compliancetrainings.com support@compliancetrainings.com

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