Complying with FDA Requirements for Deviation Investigations

JANUARY 14–15, 2021

Join This 2-day Interactive Training to Enhance Your Strategy, Process, and Outcomes

Brochure Register

Upcoming Dates

March 23–24, 2021

Who Should Attend

  • Principle Investigator
  • Substance Investigator
  • Investigations
  • Complaints
  • Drug Safety Scientist
  • Staff Investigator
  • Deviation Author
  • Deviation Manager / Director

Key Learning Objectives

  • Determining Severity and Impact of the Deviation
  • Executing a Risk Assessment and Root Cause Analysis
  • Conducting Interviews with Key Stakeholders
  • Establishing the Corrective and Preventive Actions Required
  • CAPA Assignment and Implementation Team Assignment
  • Components of a Deviation Investigation Report
  • Change Controls and Documentation Impact
  • Implementing Physical and/or Cultural CAPAs
  • Determining Sustainability of the Deviation Remediation
  • Process Flow and Timeline Requirements

Quick Overview

Attendees will be provided an overview of how to comply with FDA requirements for deviations investigations!