Root Cause Analysis Training Course

The Root Cause Analysis Training Course can be delivered in a hotel, one of our offices, your premises or online via a virtual classroom. The course content can be tailored to meet your requirements. Request a quote for an onsite or online virtual course for an agreed number of delegates from your site.

The Root Cause Analysis Training Course covers areas that will facilitate a better understanding of how to execute a root cause analysis process.

Techniques and tools for analysis of situations and events that require root cause analysis are examined to provide a structured and comprehensive approach. Terms, definitions, use of quality risk management, data analysis tools and the impact of human factors are considered during the course.

Course activities include applying quality risk management tools and root cause analysis to potential real case scenarios.

• Investigate what a non-conformance or deviation is
  • Terms, acronyms and their application
  • How to better define the problem or non-conformance or deviation situation or event
  • Consider misconceptions when defining the problem or non-conformance or deviation situation or event

• Reflect on regulatory expectations
  • Regulatory requirements
  • Common FDA and EU regulator inspection findings

• Investigate use of problem analysis to enable understanding and a structured and comprehensive approach
  • Techniques for date collection such as walk through, variance analysis, mitigation strategy analysis and interview best practice
  • Utilise risk management techniques
  • Review of different methods such as Cause and Effect, Flow and Process Charts, 5 Whys and others
  • Examine different types of causes including probable, contributing and actual root cause
  • Methods for verifying root cause

• Investigate the subject of Human Error
  • Review human characteristics and factors that could play a role in human error
  • Identify different types of human failure
  • Review ways of addressing human failure

• Apply and review non-conformance or deviation case studies to enhance course learning
  • Identify potential deviations and what needs to be done
  • Use different potential real activities to apply non-conformance or deviation

This course can be delivered to a group of up to 12 delegates at your premises or as an online virtual classroom course for an agreed number of delegates from your site. Request a quote.

“I have a much better understanding of non-conformance and root cause analysis. This includes how I can successfully apply this to my role in complaints.”
Smith & Nephew Ltd

“Very good training materials. Trainer is very knowledgeable and was able to answer various questions and concerns.”
Smith & Nephew Ltd

“Trainer allowed time for feedback and group discussion.”
Smith & Nephew Ltd

“Very good relevant and up to date content. Very knowledgeable trainer.”
Smith & Nephew Ltd

“New tools and a framework to apply them. Clear information and good practical tasks.”
Smith & Nephew Ltd

ITS’ Regulatory Compliance Trainer, Dr Jennifer Thompson, has over 20 years of experience in the pharmaceutical sector in computer systems validation and IT infrastructure controls and compliance and has delivered projects for a wide range of companies in the UK, EU and USA including GlaxoSmithKline, Novartis Healthcare, Lonza Biologics, Elan Pharmaceuticals, Hoffman LaRoche and others. Her experience covers computerised systems used in manufacturing, laboratories, enterprise systems and clinical trials management. She has written articles and given presentations on a wide range of topics and contributed to the GAMP® Good Practice Guide “A Risk-based Approach to GxP Process Control Systems” and “The Risk Based Compliance Handbook” by Siegfried Schmitt (Paraxel).

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