FDA Latest Trends: Are You Ready For the New Part 11 Tag-Along Inspections?
Click here to register for this seminar
Date: February 7, 2012
Topic: FDA Latest Trends
Speaker: Virginia L. Corbin, Manager, Corporate Compliance Marketing, Waters Corporation
Location: Pharmatek Laboratories, Inc.
Presentation Summary
Are you ready for the FDA’s new tougher focus on Part 11? In May 2010, the FDA announced the “tag along” inspections for Part 11. This was done because of the numerous problems with data integrity, and the fact that the FDA does not fully trust what the pharmaceutical industry is saying about the impact of Part 11. We will look at the FDA’s core expectations and what they will be looking for. Fore warned is fore armed.
About the Speaker
Virginia L. Corbin earned her Bachelors of Science in Organic Chemistry from Stanford University in Palo Alto, California. Virginia has been employed at Waters Corporation since 1988. In her role at Waters, she has been responsible for CGMP compliance, and has been the Corporation’s interface with the FDA on new regulations affecting the software industry. Virginia is responsible for the worldwide FDA compliance program at Waters Corporation. She is responsible for compliance of Empower and MassLynx software products for the regulated industry.
Ms. Corbin is the subject matter expert at Waters on software validation and implementation of qualification products to meet the requirements of the regualted industry worldwide. Prior to her current position, Ms. Corbin has also served as Director of Regulatory Affairs at Waters, and coordinated the ISO 9001/TickIT certification for software development and design. Ms. Corbin worked on the PDA TR-32 task group, GERM, and Computer Systems Validation task group. Ms. Corbin had 25 years of experience as a chemist, lab manager, and software evaluator in the pharmaceutical industry prior to joining Waters. Ms. Corbin is an invited speaker and has lectured extensively on compliance issues at various technical symposia around the world .
|
