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Date: 24th June, 2008

Location: Web Seminar, USA

Summary:
Pharmaceutical - Training

Good Laboratory Practice (GLP) for non-clinical laboratory studies (21 CFR 58) is intended to support research applications or marketing permits for products regulated by the FDA. In vivo or in vitro experiments of test articles are intended to determine their safety throughout the quality and integrity of the data.

This presentation focuses on common GLP problems faced in the industry, including pitfalls in areas such as laboratory equipment, instrument and computer validation, record keeping, documentation controls, data integrity and the evaluation of deviations and non-conformances.

This live and comprehensive web seminar will address sections pertaining to Part 58 from an FDA perspective, focusing on auditing and compliance techniques to prevent possible objectionable findings during a regulatory audit. The web seminar is designed for non-clinical laboratory professionals, including pharmaceutical, biotech, medical device, R&D and discovery work related to analytical laboratory operations as well as contract laboratories, manufacturers and industry consultants.