First Annual CAPA Congress Real-Life Case Studies for Pharma
Product Details
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, Elan Pharmaceuticals — 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
- Why Elan is focusing on CAPA for GCPs and GLPs
- What Wyeth has learned about CAPA trend analysis
- Plus ... two top CDER enforcement officials on the FDA’s CAPA enforcement plans
Conference Co-Chairs
Peter Calcott, Ph.D., Co-Chair, President, Calcott Consulting |
Jim Darnell, Co-Chair, President, CompliaPharm LLC |
It’s a fast-paced day and a half featuring straight-from-the-conference-room case studies with:
- Kenneth Wexler, Senior QA Compliance Analyst, Boehringer Ingelheim Pharmaceuticals
- Boris Videlov, Director of Compliance & Quality Management, Forest Research Institute (subsidiary, Forest Laboratories)
- Edit Szocs, CAPA Manager, Sanofi Pasteur
- Janice Wilson, PhD, Vice President of Quality Assurance & Compliance, Elan Pharmaceuticals
- Nancy Fulginiti, Global Quality & Compliance, Pharmaceutical Network Quality, Wyeth Pharmaceuticals
Plus, we’ve invited top officials from CDER to update you on tough new FDA enforcement plans — the latest on what the agency expects from you:
- Edwin Rivera-Martinez, Chief of Manufacturing Assessment and Preapproval Compliance, CDER, FDA
- Richard Friedman, Director, Division of Manufacturing & Product Quality, Office of Compliance, CDER, FDA
The venue is the Bethesda North Marriott Hotel & Conference Center, located a stone’s throw from FDA headquarters, the NIH and National Naval Medical Center/Walter Reed Army Medical Center campuses. There’s fine shopping and dining just minutes away in Bethesda and Rockville. With health reform the No. 1 topic in Washington, what better time to visit the nation’s capital?