Deciding When Web-based Seminars

FDAs Revised Draft Guidance on Medical Device Changes and the 510k - Webinar By GlobalCompliancePanel This webinar will discuss the new draft guidance document from the FDA: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated July 27, 2011. Wednesday, January 25, 2012 10: 00 AM PST | 01: 00 PM EST  more...

A Practical Look at Discipline and Termination - Webinar By TrainHR This webinar takes a practical look at discipline and termination as part of effective performance management. You'll learn about different kinds of discipline policies and some of the legal implications of using discipline. You'll also explore some best practices for deciding: when and what kind of discipline to use, how to document it, and how to implement it. Importantly, you'll also look at  more...

Medical Device Changes and The 510k - Webinar By GlobalCompliancePanel ...sis activities. The company is held fully responsible for deciding when a new 510(k) filing is warranted. Growing high-profile field problems indicate that change control and ita ™s effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis. A growing push by the Agency to strengthen the 510(k)  more...

How to Prepare and Submit a Bullet Proof 510k and Latest FDA Proposed Changes to the Process - Webinar By GlobalCompliancePanel ...ted with Premarket Notification 510(k) submissions * Deciding When to Submit a 510(k) for a Change to an Existing Device * What happens if FDA requires additional information and data and your responsibilities Interactive Q&A, Wrap-Up and Adjourn * Q&A with all attendees * Group discussion and review of recent 510(k) clearances and proposals and recommendations between  more...