Overview: Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Areas Covered in the Session: FDA and EU analytical instrument requirements Most common inspection problems Recommendations for firmware and software validation Roles and responsibilities: QA, manufacturer, user Qualification of existing systems Who Will Benefit: Laboratory Managers and Staff Analysts QA Managers and Personnel Regulatory Affairs Training Departments Speaker Profile: 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 Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: [email protected]