Root Cause Analysis and CAPA

Root Cause Analysis and CAPA for Effective Quality Improvement

Have you have ever wondered why you seem to investigate the same thing time and time again, or have to regularly raise the same corrective actions?  

 

Maybe the improvements you made are not as effective as you’d hoped or perhaps you are struggling to reach a root cause. This course introduces Root Cause Analysis (RCA), problem solving and Corrective and Preventive Actions (CAPAs), which all play a part in any effective quality system. Continuous improvement, RCA and CAPA are a requirement of EU GMP chapter 1 and ICH Q10. They are also present in the US via the FDA Guidance for Industry on Quality Systems.  

 

Spread across two days, this course takes you through the process of identifying problems and gathering information to help with investigative or problem-solving activity. It demonstrates how to apply several common tools and techniques to try and establish root cause - essential to make the desired improvements.   

 

Insightful and interactive, with workshop exercises to reinforce learning, this training addresses the use of risk management as well as steps to avoid human error. The course closes by considering what a problem-solving organisation looks like with a dip into the world Lean and Six Sigma used by many to underpin their operational excellence strategies. 

 

Interested in Root Cause Analysis & CAPA training for your team? Contact us today. 

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Duration
2 days
CPD Hours
14 hrs
Locations
  • Online

Who Should Attend

This course is suitable for anyone involved in problem solving in a regulated environment. You may be involved in problem solving as part of continuous improvement through operational excellence activities, risk management, investigating causes of non-conformances such as audit findings. You might be in an operational, quality or other similar role. You might be new to the team or experienced but with limited formal training. Either way this course would be ideal for you. 

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Key topics

This course includes the following topics: 

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    Problem investigations and regulatory expectations

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    Current regulatory findings  

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    Understanding problems & event capturing 

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    Overview of Root Cause Analysis 

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    Brainstorming 

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    Fishbones 

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    Pareto analysis 

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    The five-whys 

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    Human error 

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    Pareto Analysis 

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    Out of Specifications (OOS) 

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    Risk assessment and management 

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    Investigation reporting 

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    A problem-solving organisational culture 

Learning Outcomes

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

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    The regulatory background to RCA investigations and corrective and preventative actions

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    Risk analysis 

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    The use of investigations in both prospective and reactive situations 

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    The tools and techniques that can be used in investigations to identify probable root cause 

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    The requirements of a CAPA system for effective implementation of actions 

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    The importance of documenting the process used 

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    The tools and techniques for a problem-solving organisation focused on continual improvement 

Meet your expert tutors

Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you. 

Andy Martin

Andy Martin

With over 35 years of pharmaceutical industry experience, Andy began his working life as a Microbiologist in 1985, later progressing to QA Microbiology Manager. During his long career, Andy has gained experience in across a wide range of QA and QC activities. In 2003, Andy become RSSL’s Pharmaceutical Training Manager with responsibility for providing insightful commercial training courses for those looking to enhance their knowledge and prospects.
Frequently asked questions

If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.

What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

Very insightful

An insightful course, providing the knowledge of when and how to use the appropriate RCA tool to get to the root cause of a problem.
Anonymous
IVC Brunel Healthcare - QA&QS Manager

A great tutor

Andy Martin had a wealth of experience in GMP Manufacturing and he was able to convey this knowledge to the subject matter
Shaun Stillwell
Valneva Scotland Ltd

Knowledgeable and enthusiastic trainer

The trainer was very enthusiastic and had a lot of knowledge to share with the group, which kept us focused. He allowed us to use examples from our own work experience and was able to offer examples of how he had completed RCA so that we could put his examples into context. This course contains a lot if information to help during investigations and to plan effective CAPAs.
Mandy Sibley
Lloyds Clinical Limited

Interesting, insightful and interactive

This course was interesting, insightful and interactive. It was interesting to get a bit more background on the regulations and the other tools available for RCA, and good to understand that one method does not suit all investigations. The tutor was very knowledgeable and explained things clearly.
Miriro Mbirimi
Lloyds Clinical Limited

Book Your Place

Root Cause Analysis and CAPA
15 Jul 2025
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Online
03 Dec 2025
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Online
£1170 excl VAT
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Bespoke Training

We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.

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Special Offers

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

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Why choose RSSL?

As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.

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    More than 30 years of experience upskilling pharmaceutical professionals

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    Small-group training adjusted to individual learning styles and needs

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    50+ training courses accredited by recognised industry bodies

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    Combination of off-the-shelf and bespoke training packages

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    Courses and consulting led by experts in the entire pharmaceutical life cycle

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    Opportunity to share and learn as part of a diverse community