Back by Popular Demand! Webinar Rebroadcasts

Webinar Rebroadcasts

Buyers have spoken – and the FDA is responding. By popular demand, FDAnews is rebroadcasting these best-selling events from earlier in 2011. Hundreds registered for these invaluable webinars the first time around.

Tuesday, Dec. 6, 2011
11:00 AM
New EU Annex 11 Rules: Part 11's Get-Tough European Cousin (more than 300 attendees attended its original airing)

1:30 PM
A World Apart:
Understanding Differences in E.U. and U.S. Medical Device Adverse Event Reporting (more than 150 attendees attended its original airing)

Wednesday, Dec. 7, 2011
11:00 AM
Off-Label Promotion — The Elephant in the Room (more than 100 attendees attended its original airing)

1:30 PM
eMDR Conversion and Implementation:
Presentation and Q&A with an FDA Expert (more than 100 attendees attended its original airing)

Thursday, Dec. 8, 2011
1:30 PM
Spreadsheet Validation (more than 100 attendees attended its original airing)

This is your best opportunity – and last chance – to attend FDA's highest-rated events. Wrap up your 2011 on a high note ... register TODAY for one, two or all of these special one-time-only 90-minute encore presentations.

Tuesday, Dec. 6, 2011
11:00 AM
New EU Annex 11 Rules: Part 11's Get-Tough European Cousin
An Expert Guide to Expanded System Validation, Risk Management and Documentation
Annex 11 now requires your company to manage risks throughout the life of any computerized system used in a regulated activity. The new rules will mean retooling validation, risk management and documentation, including everything from electronic signatures and simple spreadsheets to product quality systems and complex, companywide networks. Are you fully up to date ... or at risk for sanctions for noncompliance?

1:30 PM
A World Apart:
Understanding Differences in E.U. and U.S. Medical Device Adverse Event Reporting

The FDA estimated that more than 10,000 adverse event reports for medical devices are submitted annually in the U.S., with an even higher number reported in the E.U. Failure to understand adverse event reporting in either the U.S. or the E.U. can result in faulty clinical trials and, even worse, warning letters.

Wednesday, Dec. 7, 2011
11:00 AM
Off-Label Promotion — The Elephant in the Room
Understanding the Regulatory and Product Liability Concerns of FDA/DOJ Enforcement

The Justice Department has been working on 200+ investigations of off-label violations involving some 500 products, and the FDA's Office of Criminal Investigations (OCI) maintains a special prosecutions staff to look into illegal off-label promotion of approved devices and drugs. Yet far too many drug and device company employees simply don't know the rules. Training is spotty, sometimes nonexistent. Here's how to learn what you need to know to protect your company — and yourself — from fines, lawsuits, even prison time.

1:30 PM
eMDR Conversion and Implementation:
Presentation and Q&A with an FDA Expert

A final rule from the FDA now requires devicemakers to begin filing medical device reports electronically. Once you begin, the FDA will expect you to file everything electronically, including: initial reports; supplemental/follow-up reports; file attachments (as PDFs or zips); and source (e.g., user facility) reports. Still have questions? Here's your opportunity to hear an FDA official answer them.

Thursday, Dec. 8, 2011
1:30 PM
Spreadsheet Validation
Tools and Techniques to Meet FDA Requirements

What if you could perch on the shoulder of an expert on spreadsheet validation ... look on in real time as he posts entries and manipulates cells ... ask why he does this instead of that ... and get feedback? What if you could discover the tips and tricks that will help you streamline your spreadsheet validation process for quick-and-final FDA approval? Well, you can, in this crash course in bulletproofing your Microsoft Excel spreadsheets.