Application of GMPs to Analytical Laboratories

Compliance with current Good Manufacturing Practices (cGMP) requirements is essential in order to create products that have quality, purity, proper identity, strength, and are safe. All laboratory analysts must follow cGMPs in order to create effective products and comply with all quality standards. Topics in this course include: Laboratory Documents, Laboratory Practices, Raw Data, Method Validation, Calibration, Training, OOS, and Computer Systems. After completing this course, learners will be able to identify cGMP requirements as they apply to analytical laboratory practices. 

Identify cGMP requirements as they apply to analytical laboratory practices. Recognize key concepts related to laboratory documents, raw data, and out-of-specification (OOS) test results, and the requirements for laboratory training. Recognize laboratory calibration requirements, method validation, and computer systems for use in analytical laboratories.