Training Program Title

What You Should Know Before the FDA Arrives

CTSA Hub Administered

no

Contact Information

Please contact SOCRA by emailing office@socra.org or by calling 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. This Course will discuss the steps involved in an FDA inspection and will address best practices in responding to FDA questions. The faculty will discuss what the FDA is instructed to look for when conducting an inspection and review recommendations regarding what to do after the inspection. The FDA's Compliance Program Guidance Manuals will be explained.

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

Regulation, Audits

Digital Commons Disciplines

Medicine and Health Sciences

Public

yes

Cost to Access

yes

Competency Domains

Clinical Trials Operations; Study and Site Management

Learning Objectives

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

  1. Discuss the steps of an FDA audit.
  2. Discuss how to respond to FDA questions
  3. Have an understanding of the FDA's Compliance Program Manuals
  4. Understand what the FDA auditor is looking for.
  5. Discuss how to review recommendations from the FDA after an Audit.

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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