Complying with FDA Requirements for Deviation Investigations

JUNE 29-30, 2021

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

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!