Learning from Recent FDA Warning Letters Related to Computer Validation and Part 11 (21 CFR Part 11 Compl)
Venue: Online Event
|Event Date/Time: Jul 29, 2011||End Date/Time: Jul 29, 2011|
In July 2010, the FDA announced that it will conduct a series of inspections related to 21 CFR Part 11. The FDA made it very clear that Part 11 is in effect and will be enforced according to original Part 11 and the Guidance from 2003.
While this guidance leaves a lot of room for interpretation and uncertainty, an excellent way to find out FDA's expectations is to learn from recent Part 11 related warning letters. From 2007-2011, there have already been more than 30 warning letters with deviations related to computer system validation and Part 11 compliance, some with disastrous consequences for inspected companies.
This webinar will explain the strategies to avoid warning letters using examples of recent 483â€™s and warning letters related to computer system validation.
For easy implementation, attendees will receive
SOP: Define and Document Scope and Controls for Part 11.
Checklist: Part 11 Compliance.
15 Case Studies.
All well documented with graphical workflow, step-by-step description, recommendations for Part 11 requirements and justifications for the FDA and your management
20+ Warning letters and Inspectional observations related to 21 CFR Part11, all from 2006-2009.