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GMP, GAMP® & Validation Training > Validation Training > Introducing GMP, Root Cause Analysis and Understanding Validation Training Programme


Introducing GMP, Root Cause Analysis and Understanding Validation Training Programme

Course Title:Introducing GMP, Root Cause Analysis and Understanding Validation Training Programme
Course Delivery:

Introducing GMP, Root Cause Analysis and Understanding Validation Training Programme 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.

Course Duration:3 days
Course 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.

Course Content:

Day 1

  • Understand the need for GMP
    • What is GMP?
    • GMP and its link with Quality Assurance and Quality Control
  • Define the GMP guidelines and how agencies enforce them
    • What are the relevant regulations?
    • How the main regulatory agencies audit and 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
    • Plan for workplace improvements

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
    • 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

Day 3

  • Investigate the history and requirements for validation
    • What is validation?
    • Regulatory requirements and expectations
  • 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
    • Analyse real scenarios
    • Determine suitable actions for workplace improvements


Onsite Courses:

The Introducing GMP, Root Cause Analysis and Understanding Validation Training Programme can be delivered in a hotel, one of our offices, or your premises. The course content can be tailored to meet your requirements. REQUEST_QUOTE


Further Information:
Request more information on this training course.



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