This course provides an introduction to the requirements of systematic failure investigation (FI) and corrective and preventive action (CAPA) practices as described in ICH Q9 and made a regulatory requirement in Europe by Annex 20 of the Guide to GMP, and in the USA by the Federal Register/FDA Guidance for Industry.

The course is focused on company responsibilities within a quality risk management system, and several investigational tools are explored to help build up knowledge of techniques that might be used by a company to provide a structure for systematic investigation of failure.

Numerous exercises are run throughout the course to provide realistic examples of events requiring investigation, providing an opportunity to practice investigation and writing up of corrective actions within teams. Examples of the use of, and outputs from, more complex techniques are presented.

This course is suitable for personnel involved in risk assessment, failure investigation, root cause analysis and CAPA management at policy maker or practitioner levels in the organisation.

Learning Outcomes

By the end of the course you will be able to:

Understand the regulatory background to FI and CAPA

Understand risk analysis

Understand the use of FI in both prospective and reactive situations

Understand tools and techniques that can be used in FI to identify probable root cause

Understand the requirements of a CAPA system for effective implementation of actions

Appreciate the importance of documenting the

Identify company policy and procedure required to meet regulatory requirements

Programme

Failure Investigations and Regulatory Expectations

Current Regulatory Findings – recent data from FDA & MHRA

Documenting Failure Events

Investigation of Failure Events – Root Cause Analysis

Investigation of Failure 2 - OOS

Risk Assessment and Management

Risk Management Tools

Pareto Analysis

CAPA

Monitoring, Interim reports

Quality System Interactions

Includes a number of interactive exercises