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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