This webinar will discuss medical device changes and the 510(k) process. It will provide guidance on analyzing product changes and determining when a new 510(k) submission is required. The webinar will cover using the FDA's K97-1 guidance document and considering manufacturing, labeling, technical, and material changes. It will also discuss implementing formal change control methods and documenting rationale for 510(k) submissions or non-submissions. The 90-minute webinar presented by John Lincoln will be useful for medical device companies in R&D, engineering, quality, and regulatory roles.

1. Webinar On Webinar On Medical Device
Changes and the 510(k)
Presented By John E. Lincoln
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Hosting By
Compliance Trainings
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Tuesday, March 31, 2015 at 13:00 Hrs

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Webinar Description:
Webinar On 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“
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Memorandum (they recently pulled their proposed new draft Guidance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.
Product Id MD1541
Category Medical Devices
Scheduled On Tuesday, March 31, 2015 at 13:00 Hrs
Duration 90 Minutes
Speaker John E. Lincoln
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3. Areas Covered in the Session :
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.
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.

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