COMPLIACNE TRAININGS 2014 - Webinar On - Medical Device Changes and the 510(k)

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Category Compliance Trainings, Medical Device, Regulatory Affairs, FDA, Pharmaceuticals, online training, Healthcare, Regulatory Compliance, FDA's current K-97-1 Memo, 510(k) Device Modifications, K97-1, Quality Assurance

Deadline: February 12, 2014 | Date: February 12, 2014

Venue/Country: Online, Canada, Canada

Updated: 2013-12-26 16:15:50 (GMT+9)

Call For Papers - CFP

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 The U.S. FDA has its current K-97-1 Memorandum (they recently pulled their proposed new draft Guidance Document, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device").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

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