Understanding 483s and Surviving Them

Discusses steps that investigators and clinical sites can take to understand and respond to an FDA Form 483.

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About this Webinar

This webinar focuses on the FDA inspection process, the role of the FDA Form 483, and what it means for a clinical investigator or research site to receive one. The webinar provides important information to help investigators and sites implement remediations and plan for long term success at the site. It concludes by explaining the required actions with respect to the FDA post 483.

Webinar Demo:

Release Date: March 31, 2022

Language Availability: English

Suggested Audiences: Clinical Investigators, Compliance Professionals, Contract Research Organizations (CROs), IRB Members, Research Administrators, Researchers, Sponsors

Organizational Subscription Price: $300 per year/per site or included as part of an annual subscription to our All Access Webinar Package
Independent Learner Price: $49 per person

Webinar Content

Understanding 483s and Surviving Them

Presented by: Theresa A. O’Lonergan, PhD, MA - Velocity Clinical Research

Learning Objectives:

  • Explain the FDA inspection process and purpose of FDA Form 483.
  • Identify the most common FDA citations for clinical sites and investigators.
  • Discuss structure of an FDA Form 483 and methods for assessing findings (including observations and violations).
  • Consider appropriate responses to an FDA Form 483.
  • Review actions to correct and prevent inspection findings.

Recommended Use: Required
ID (Language): 20582 (English)

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