Education Sessions
Validation Hot Topics (702)
| 27 October 13.30-17.00 | Track: Efficient and Effective Compliance |
ISPE CEUs: 0.4
(PDF Current as of 2 October 2008)
Take this opportunity to hear from industry leaders on the latest guidance documents from the FDA as well as trends and issues arising from new Warning Letters and 483’s issued by the FDA in 2008. In a constantly changing compliance environment, it is essential to stay up to date with the expectations of the regulators. The session will be very interactive, including panel question and answer. Visit www.ISPE.org/annualmeeting for session updates.
Session Leader
- Loretta Vuolo-Schuessler, Project Manager, GlaxoSmithKline, USA
Session Speakers
- Steven Coates, Director Computer Systems QA, Pfizer, USA
- Carl Dourambeis, QA Director, STARLIMS, Canada
- Richard Friedman, Dir, Mfg & Product Quality, FDA/CDER, USA
- Judith Samardelis, Sr Mgr Computer, Ent & Lab Sys, Wyeth BioTech, USA