Root Cause Analysis and CAPA
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.
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.
This course includes the following topics:
Problem investigations and regulatory expectations
Current regulatory findings
Understanding problems & event capturing
Overview of Root Cause Analysis
Brainstorming
Fishbones
Pareto analysis
The five-whys
Human error
Pareto Analysis
Out of Specifications (OOS)
Risk assessment and management
Investigation reporting
A problem-solving organisational culture
By the end of the course you will be able to understand:
The regulatory background to RCA investigations and corrective and preventative actions
Risk analysis
The use of investigations in both prospective and reactive situations
The tools and techniques that can be used in investigations to identify probable root cause
The requirements of a CAPA system for effective implementation of actions
The importance of documenting the process used
The tools and techniques for a problem-solving organisation focused on continual improvement
Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you.
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.
| Yes, the Root Cause Analysis and CAPA course can be delivered in-house for your organisation. This can be arranged as an on-site course at your premises, or as a virtual tutor-led in-house course. Please see our In-house Training page for details. |
| Places will be available for you to book unless it states ‘Full’ next to your chosen Root Cause Analysis and CAPA course date. When this occurs, we operate a waiting list service. |
| Yes, we welcome bookings from self-sponsoring individuals. Once your booking has come through to us, we will ask you to complete a new customer form and provide a scanned copy of your photographic ID so that we can raise an account for you on our systems. |
| You will need to first register yourself on our booking system by selecting the Root Cause Analysis and CAPA course date that you wish to book your colleagues onto, then: - Add the number of people you wish to book onto the course - Register yourself as the booker and complete the fields accordingly - Add the details of those you wish to book for - Complete your order. |
| You will receive an automated email confirming your booking details for the Root Cause Analysis and CAPA course. 10 days before the start date, if the course is confirmed to run, you will receive another email including the final course details. If the course is to be held virtually, the online registration and joining instructions will also be included. |
| Usually, this 2-day Root Cause Analysis and CAPA course is delivered live by our tutor, virtually on the Adobe Connect training platform. If you are looking for in-person training only, please get in touch with the team to discuss your needs via trainingsales@rssl.com or +44 (0)118 918 4000. |
When online, this course begins at 08:45am, although we request that you login at 08:30am for registration. For our in-person courses, refreshments are available from 08.30am, for a 08:45am start. The standard finish time is 17:00pm, though some courses will finish slightly earlier or later.
Please review your course confirmation email to double check the exact start time of your specific course. If you need an exact finishing time to allow for travel arrangements, please contact us via trainingsales@rssl.com or +44 (0)118 918 4000.
| Your invoice will be sent approximately 30 days prior to the course start date. If you are a new customer to RSSL, shortly after we receive your booking, you will be asked to complete a New Customer Form so that an account can be created for you on our finance system. |
| Yes, companies wishing to book multiple employees on one of our standard training courses (excluding IRCA Lead Auditor courses) can benefit from our group booking discount. This discount is only applicable to bookings made for the same course on the same date. Please contact trainingsales@rssl.com with your requirements and we will be happy to provide more information on the best deal available for you. |
| Yes, we offer NHS Trusts a 20% discount on ALL our courses, including our Qualified Person training programme. When booking your course/s enter 'NHS' in the discount code field so that your discount can be applied on your invoice. Please note that the NHS discount code is only valid when the booker uses a NHS email address. |
| Yes, certificates of attendance are issued after we have received payment in full for the course. If you have not received your certificate, please contact your own finance department to confirm if they have sent payment to us. All certificates are issued electronically by email. |
| As RSSL run all of our virtual courses on Adobe Connect, we recommend that you download the latest version of the Adobe Connect Application at the time of your course - click here to visit the download webpage. Please see our 'minimum requirements' document for further details on what you'll need to attend our virtual courses. You can test that the Adobe Connect application works for your organisation by completing the RSSL Adobe Connect Function Test. |
| Yes, we are more than happy to welcome delegates from all over the world. Our virtual tutor-led courses are particularly popular with international attendees. All we request is that you have a good understanding of written and spoken English so that you can get the most out of the course. If you wish to attend an in-person course, please also check any visa requirements and await RSSL's full course confirmation before booking your travel to the UK. |
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We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
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.
More than 30 years of experience upskilling pharmaceutical professionals
Small-group training adjusted to individual learning styles and needs
50+ training courses accredited by recognised industry bodies
Combination of off-the-shelf and bespoke training packages
Courses and consulting led by experts in the entire pharmaceutical life cycle
Opportunity to share and learn as part of a diverse community
