cGMP for Investigational New Drugs (IND) in Phase 1 Clinical Trials

This online course is intended to provide access to training and continuing education that will promote quality clinical research, protect the welfare of research participants and improve global health. All drugs manufactured for use in clinical trials must comply with Good Manufacturing Practices. Drugs for Phase I clinical studies must comply with statutory CGMP. Drugs for human use must not be adulterated. The manufacturer must assure the drug is safe and has the identity, strength, quality, and purity which it is represented to possess. The FDA's guidance document covering this topic will be discussed. This is a 60 minute internet media player video of a voice over slide show. A quiz concluding the presentation will summarize the topic and evaluate your understanding of the material.

Duration: 1 - 4 hours

Advanced

Paid