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CPD Hours: 14
Classroom, online, in-house
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 those improvements you’ve made recently aren’t as effective as you’d hoped. Well, you are not alone but maybe you are struggling to reach a root cause. This course provides an introduction to root cause analysis (RCA), problem solving and corrective and preventive action (CAPA) which should be part of any effective quality system. Continuous improvement, RCA and CAPA is certainly a requirement of EU GMP chapter 1 and ICH Q10 as it is in the USA via the FDA Guidance for Industry on Quality systems.
The course takes you through the process of identifying problems, gathering information to help with an investigation or problem-solving activity, and then applying a number of common tools and techniques to try and establish root cause.
It addresses the use of risk management as well as steps to avoid the, all to often accepted, human error. Taking action based on root cause is then essential in order to make the desired improvements. We finish by looking at what a Problem-solving organisation looks like with a dip into the world Lean and six sigma used in many organisations to underpin their operational excellence strategies. In many cases workshop exercises are used to practice the techniques discussed.
This course includes the following topics :
By the end of the course you will be able to understand:
We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.
A microbiologist with over 35 years experience, Andy Martin has worked in numerous QA management roles, spanning a range of sterile and non sterile dosage forms, and gained valuable experience in regulatory inspections, failure investigation, risk assessment and operational excellence activities including Lean Six Sigma Kaizen events.
Management of GMP inspections
This is a highly practical course covering management of GMP inspections from initial preparation, to hosting the actual inspection and follow up from the inspection.