Understanding the USP 1058 Analytical Instrument Qualification
About This Event
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]