FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. Just in the last 24 months FDA issued more than 30 warning letters with citations Part 11 violations. Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems.
There are many questions about the program, e.g., what inspectors are looking at and what are major findings. The seminar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.
Areas Covered in the Session:
Who Will Benefit:
Dr. Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com
Compliance4All DBA NetZealous,
Event Link : http://bit.ly/Preparing_for_FDA
LinkedIn Like us
Twitter Follow us
Facebook Like us