Complying with FDA Requirements for Deviation Investigations

JUNE 29-30, 2021

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

Brochure 

Upcoming Dates

June 29–30, 2021

Who Should Attend

This training course is designed for anyone and safety or compliance looking for an educational course, including:

  • 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!