Global Compliance Webinar

On Wednesday, April 7, Global Compliance will offer a Webinar on FDA’s New Enforcement of 21 CFR Part 11.

FDA’s new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part 11 interpretations. Just in 2007/2009, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that ‘enforcement discretion’ as stated in the 2003 guidance is not applied any more.

Areas Covered in the Session:

* FDA’s current inspection and enforcement practices

* FDA’s new interpretation: learning from FDA guidance, and recent FDA conference presentations and discussions

* Learning from FDA inspection reports

* Part 11 and the new EU Annex 11: similarity and differences

* Strategy for cost-effective implementation of the ‘new’ Part 11:A six step plan

* Recommended changes to existing Part 11 programs to reduce costs

* Justification and documentation for the FDA and your management

Instructor Profile: Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books “Validation and Qualification in Analytical Laboratories, and “Validation of Computerized Analytical and Networked Systems.”

Source: Global Compliance Panel