Training Program Title
cGMP for Investigational New Drugs (IND) in Phase 1 Clinical Trials
CTSA Hub Administered
Contact us by email at firstname.lastname@example.org or by phone at 215-822-8644.
Training Program Description
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.
Product development, Regulation, Best practice, Research study management
cGMP, IND, FDA
Digital Commons Disciplines
Cost to Access
Ethical and Participant Safety Considerations; Medicines Development and Regulation; Clinical Trials Operations
At the completion of the webinar, participants should be able to:
Discuss the FDA's guidance document covering CGMP for clinical trials.
Clinical Research Professionals (other than PI)