Preparing for FDA GLP Audits

Introduction

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 live and interactive BenAstrum web training course will concentrate 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. In addition, the course will also 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 course 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.

Learning Benefits:

• Clarifying concepts pertaining to 21 CFR 58
• Understanding laboratory requirements under 21 CFR 58
• Auditing techniques applicable to documentation controls
• Understanding the differences between instrument calibration, qualification and computer validation
• Evaluation of security and data integrity considerations on record keeping
• Complying with FDA requirements for method validation
• Analyzing non-conformances and conducting investigations

Who Can Benefit:

• QA/QC Directors, Managers and Supervisors
• Internal Auditors and Regulatory Affairs
• Education/Training Managers and related personnel
• GLP/GMP Compliance
• Laboratory Directors, Managers, Supervisors and Scientists
• Validation Scientists
• IT/IM Managers and personnel (Laboratory Instrument & Software Validation)
• Technical and Analytical Services
• Metrology Groups
• Engineering

Please click here for the course agenda