| Starts: | Wednesday December 02, 2009 at 8:30am |
|---|---|
| Ends: | Thursday December 03, 2009 at 12:15pm |
| Event Type: | Conference |
| Region: | Washington D.C. Metro Area |
| Location: |
Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Rd Rockville, MD 20852 US |
| Price: | $1,497 |
| Website: | http://www.fdanews.com/conference/detail?eventId=2829 |
| Industry: | pharmaceuticals |
| Keywords: | Drug, Enforcement, Procedures, Solutions, Pit Teams, Pharmacovigilance, Quality, Investigations, Trend Analysis, Cder, Biologic, Fda, Capa, Compliance |
| Intended For: | |
| Organization: | FDAnews |
Come to Washington, D.C., Dec. 2-3 and discover how industry leaders — Boehringer Ingelheim, Wyeth, Sanofi Pasteur, Forest Labs — meet and solve the drug and biologic industry’s most vexing FDA challenge, CAPA compliance.
The FDA’s new enforcement plan that sent shockwaves through the industry makes one thing clear: Developing a successful CAPA program has never been more important.
But creating an FDA-proof CAPA has never been easy.
If only you could pick the brains of those who are coping successfully with CAPA – the best and the brightest, the industry leaders who’ve devised programs, procedures and solutions that put their companies out front with the FDA.
Well, you can.
An elite handful of compliance executives from top companies — Boehringer Ingelheim, Wyeth, Sanofi Pasteur, Forest Labs — have consented to share their hard-won secrets. Come to Washington, D.C., Dec. 2-3 and discover:
* Boehringer Ingelheim’s experience creating “PIT Teams”
* How Forest Labs integrates pharmacovigilance into quality management
* Sanofi Pasteur’s techniques for conducting CAPA investigations
* What Wyeth has learned about CAPA trend analysis
* Plus ... two top CDER enforcement officials on the FDA’s CAPA enforcement plans