Chief Advisor - Global FDA compliance,
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", Informa Healthcare.
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 Part11 interpretations. Recorded
April 7, 2010
10:00 AM PST | 01:00 PM EST,