Overview:
The purpose of the Introducing GMP, Root Cause Analysis and Understanding Validation (3 Day) Training Programme is to provide learners with the opportunity of either taking one course alone, a mix of the following courses or all three in their entirety, over consecutive days.
Content:
Day 1
Understand the need for GMP
Define the GMP guidelines and how agencies enforce them
Investigate the 4 Ps
People - adequacy, experience, training and the role of the Qualified/Responsible Person
Procedures and Documentation - from the completion of SOPs to in-process controls
Production Areas and Equipment - premises, layouts and considerations
Products and Components - incoming, handling, storage, packaging, labelling and non-conforming products
Identify potential GMP violations and their consequences
Use interactive case studies to analyse scenarios
Examine real reported incidents
Determine behaviours that improve GMP
Day 2
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
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
Day 3
Investigate the history and requirements for validation
Understand the terms and the application of validation
Discuss the terms used
Evaluate the key stages of validation
Use the basic 'V' model for a simple approach
View a CD video and answer questions
How far does Good Engineering Practice go towards meeting compliance?
Use case studies to explore the causes and implications of non compliant validation