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Individual e-Learning

 

 

Effective Investigations and Corrective Actions (CAPA)

Tools for investigating failures and deviations, and implementing root cause analyses

On this page...

 

Benefits of attending for you and your company

At the end of the course you will...

understand what an effective investigation is, and what it is not

be able to implement tools that will allow the company to rapidly determine the root causes of deviations, problems and failures

implement a sound and effective CAPA program

know which tools to use in which situations, and how to sell management on effective corrective action and implementation

be able to satisfy the regulatory authorities by performing effective and valid investigations

use the tools taught in this course to incorporate cost-saving methodologies into your company's failure investigations

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Who Should Attend

This seminar is designed for quality managers, auditors, production managers and top management interested in learning the value of good investigations, as well as how to enhance the QA investigative function as a valuable cost-savings and quality-improvement tool. Consultants, auditors and government inspectors will find this course particularly useful in enhancing their inspections and capabilities.

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Course Langauge

English

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Course Overview

When unexpected events happen — you cannot follow an SOP and need to deviate from it, or you obtain an out-of-specification test result, or your supplier’s raw materials marginally fail specification and you desperately need the material — what do you do?

A few years ago, the standard reaction to an unexpected event was to ignore it or make an attempt to quickly fix it. Today, such reactions are unacceptable when working in a GMP environment. FDA’s strategy for GMP implementation for the 21st century — part of its quality systems approach — demand that proper investigations and corrective actions take place and be documented. Not only do you need to investigate the event to determine what happened, but you need to figure out why the event happened and resolve it in a manner that prevents recurrence. It's sound GMP, and makes good business and economic sense.

A well-managed CAPA (corrective and preventive action) program not only provides effective and mandated regulatory compliance, but also yields enhanced productivity.

As part of FDA’s “GMPs for the 21st century” program, performing effective investigations into deviations and failures has become a key element of risk management and GMP improvement, and has become a key focus during regulatory inspections.

This course teaches tools and techniques that can be employed to get to the root causes of unexpected quality events, and help resolve them in a lasting, GMP compliant manner.

The course will examine actual situations, guiding participants in effective investigation resolution and determining solutions to effect proper corrective action.

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Course Outline

 
  • EU and US GMP requirements for failure investigation
  • How the GMP authorities want you to investigate failures and quality events
  • Effective investigations tools:
    – Interview skills
    – Detective skills
    – Documentation skills
  • CAPA (corrective action and preventive action programs): what they are, and what FDA wants from you
  • Being in control: essentials of a CAPA program
  • Root causes
    – what they are and how to find them
    – key considerations in effective analysis and CAPA analyses
    – when pursuit is a waste of time
  • Event and causal factors analysis
  • FDA’s out-of-specification guidance and US requirements for effective investigations
  • Out-of-specification (OOS), out-of-trend (OOT), out-of-expectations (OOE) incident investigations
  • Documentation of investigations
  • Quality event definitions
  • Tools for effective investigations:
  • Brainstorming
  • Ishikawa (Fishbone) analyses
  • Pareto analysis
  • Force field diagrams
  • Six-Sigma analysis
  • Kepner-Tregoe® analysis
  • Tools for effective fixes:
  • Failure mode effect analysis
  • Hazard and critical control points
  • Fault tree analysis
Case Studies
 

– Laboratory out-of-specification incidents
– Manufacturing failures
– Manufacturing deviations

Workshop
 

What to do when everything is going wrong — isolating problems, determining root causes, deciding on immediate fixes to stay in business

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Previous Participant Testimonials

The seminar has proven to me that my company was on the right track with the investigation program implemented a few years ago. There is, however, room for improvement and your seminar has given me the tools to make these improvements. Thank you.
Guylaine Raymond

I truly enjoyed the course: you are a great presenter! This was a great eye-opener on how to actually perform these activities.
Hugo Tremblay, Merck Frosst Canada

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