USP 1058 Analytical Instrument Qualification - 2017

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Category Regulatory Affairs, education & training, education training, compliance edtraining, usp 1058, installation qualification, 2017 compliance trainings, fda quality management system, FDA Compliance Training, performance qualification, quality control

Deadline: April 18, 2017 | Date: April 19, 2017

Venue/Country: Fremont, U.S.A

Updated: 2017-02-24 19:00:50 (GMT+9)

Call For Papers - CFP

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

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