Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity Online Training Programme

Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity Online Training Programme

Published on 17/08/2020
Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity Online Training Programme

Time: 29 September 2020 – 01 October 2020 (3-day course)

The complete programme allows learners to build a basic knowledge of validation through to the latest GAMP® 5 guidance, and then on to specific American regulatory requirements for 21 CFR Part 11 Electronic Records; Electronic Signatures.

ITS provides the opportunity of either taking one course alone, a mix of the following courses or all three in their entirety, over consecutive days.

Please see below the content that will be covered by the course:


Day 1

  • Investigate the history and requirements for validation
    • What is validation?
    • Regulatory requirements and expectations
  • Understanding 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

 

Day 2

  • Identify how GAMP® guidance was developed and the reasons behind it
    • Regulatory requirements
    • Technological innovation
    • Interpretation of rules and regulations
  • Review the Life Cycle approach and phases, including: Life cycle concepts; concept, project and retirement
    • Practical examples based upon GAMP® categories of software
    • Operational phases including:
      • Handover
      • CAPA
      • Change management
      • Security 
      • System administration
    • Latest terminology and common themes including, the relationship between qualification terminology and GAMP® 5 activities
    • V model approach for IT systems and process control systems
    • Categories of software, hardware and the validation approach
  • Introducing Quality Risk Management
    • An overview of Quality Risk Management
    • Description of the risk assessment process including sample risk assessments
  • Develop understanding of guidance for supplier activities
    • Consider help for suppliers
  • Describe regulated company activities to assure computerised system compliance
    • Elements to achieve compliance
    • Regulatory approach to audits and non-compliance
    • Areas particularly vulnerable to non-compliance for manufacturers, and supplier considerations
  • Review other GAMP® 5 guidance articles and appendices including:
    • Guidance on efficiency improvements 
    • Appendices: 
      • Management
      • Development
      • Operation
      • Special Interest Topics
      • Other General Appendices

Day 3

  • Understand what the regulation 21 CFR Part 11 is
    • What the requirements are
    • Why have the regulation?
    • The interpretation between guidance and regulation
  • Identify key terminology used in the regulation
    • Terms and definitions
  • Lifecycle of a document
    • Electronic
    • Hard copy
    • Records
  • What is in and out of scope?
    • Validation requirements for computer systems
    • Predicate regulations - what are they, where to look and why?
    • A focus on risk to records and the 'Hybrid' approach
  • Links to validation
    • Validation requirements for computer systems
  • Training
    • Requirements
    • Qualifications and experience
  • Management of systems
    • For open and closed systems
    • Physical and logical controls
  • Signatures
    • Signature/record linking
    • Their uniqueness
    • Biometrics
  • Controls
    • Password ageing
    • Procedures
    • Management responsibilities
  • Understand FDA Part 11 Guidance for Industry
    • Latest thinking and guidance
    • Why the FDA is now assessing whether companies are using the revised guidance
  • Recall problems encountered by companies applying the rule
    • Potential problem areas
    • Case studies
    • Differing scenarios/FDA warning letter reviews
    • How the FDA used to audit and report compliance issues to where they are now
  • Identify and review EU GMP Annex 11 revised guidance on Computerised Systems focusing on records and signatures
    • Review includes:
      • Corresponding GMP Volume 4 Guide, revision of Chapter 4 Documentation
      • Updates from previous revision of Annex 11
      • Cross reference to Part 11
  • Describe the GAMP® approach to 21 CFR Part 11 compliance
    • Links with GAMP® and risk assessment
    • Use GAMP® risk assessment to assess a potential real scenario
  • Explore the subject of data integrity and understand the reasons for the current regulatory focus including:
    • European and FDA regulatory guidance
    • Challenges to Data Integrity and effective strategies
    • Data Integrity control measures

If you wish to enroll yourself in the course, please secure your place here.

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