Overview:

The purpose of the Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity (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.

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.

The programme comprises Understanding Validation Training (Day 1), GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance Training (Day 2), and Interpreting 21 CFR Part 11 and Revised EU Annex 11 and Data Integrity Training (Day 3).

Content:

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