USP 1058 Analytical Instrument Qualification - 2017
- Start Date:
- Wednesday, 19 April, 2017
- End Date:
- Wednesday, 19 April, 2017 11:15am
- Health & Nutrition
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 problemsRecommendations for firmware and software validationRoles and responsibilities: QA, manufacturer, userQualification of existing systems Who Will Benefit:Laboratory Managers and StaffAnalystsQA Managers and Personnel Regulatory AffairsTraining 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: +1-800-447-9407Email: support@compliance4All.com
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Conference organized by Compliance4ALL
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.
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