Webinar Medical Device Changes and the 510(k)

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Category Food, Drugs & Biologics

Deadline: March 31, 2015 | Date: March 31, 2015

Venue/Country: Mississauga, Canada

Updated: 2015-02-27 14:28:12 (GMT+9)

Call For Papers - CFP

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"

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

Price tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada

Customer Support : #416-915-4458

Email : supportcompliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1541

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