Training Program Title

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

CTSA Hub Administered

no

Contact Information

Contact us by email at office@socra.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.

Competency Keywords

Product development, Regulation, Best practice, Research study management

Other Keywords

cGMP, IND, FDA

Digital Commons Disciplines

Medical Education

Public

yes

Cost to Access

yes

Competency Domains

Ethical and Participant Safety Considerations; Medicines Development and Regulation; Clinical Trials Operations

Learning Objectives

At the completion of the webinar, participants should be able to:

Discuss the FDA's guidance document covering CGMP for clinical trials.

Delivery Method

Online

Target Learners

Clinical Research Professionals (other than PI)

Learning Level

Skilled

Onboarding

no

Frequency

On demand

Time Needed

60 minutes

Associated Assessment

yes

Assessment Methods

Learning outcomes

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