Compliance Trainings, Canada
2015-03-31
Description : 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 : support@compliancetrainings.com Like Us On Facebook: https://www.facebook.com/events/784546744972359
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