Data Integrity: FDA/EU Requirements and Implementation


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Data integrity has been a focus for pharmaceutical regulatory inspections for a number of years and look set to remain of concern to regulators and manufacturers for many years to come. Many inspection reports from regulatory agencies around the world cite data integrity as a cause of observations and enforcement action, and actions taken by regulators to restrict the commercial activities of manufacturers on the grounds of data integrity violations have obvious serious consequences for the company concerned.

This 2-day course explains the background to the data integrity regulations and sets out the expectations of pharmaceutical regulators. All the current data integrity guidances emphasise a risk-based approach to compliance, and the course explains how to evaluate and control data integrity risks. A key resource in relation to electronic records is GAMP 5, which deals with controlling risk and managing computerised systems over their life cycle. The practices recommended by GAMP 5 will be dealt with in detail, and practical advice on the appropriate use of Excel spreadsheets given. Data integrity should not be thought of as an exclusively analytical problem, and examples of data integrity violations in production will highlight the risks during manufacturing.

The course includes practical exercises which are designed to reinforce the taught component. These include data integrity risk assessments, categories of computerised data system and conducting a data integrity audit.

Learning Objectives:

Attendees will:

  • Understand what data integrity is and why it is so important for patient safety
  • Recognise that there are many causes of data integrity breaches
  • Know the current regulatory expectations
  • Appreciate the difference between static and dynamic records, and be able to apply acceptable strategies for the retention of both types of record
  • Be able to categorise and validate GxP computerised systems according to GAMP 5
  • Understand the importance of training and quality culture in avoiding regulatory enforcement action
  • Learn how to respond to data integrity observations in inspection reports
  • Learn how to prevent, detect and remedy data integrity problems

Who will Benefit:

  • QA managers and personnel
  • Laboratory managers and supervisors
  • Production managers and supervisors
  • Analysts
  • IT/IS managers and system administrators
  • Software developers
  • Regulatory affairs
  • Training departments
  • Documentation departments
  • Consultants
  • Auditors

Companies and departments:

  • Pharmaceutical development and Quality control laboratories
  • API manufacturers
  • Medical device companies
  • Contract laboratories
  • Clinical research organisations
  • Suppliers and service providers of instruments and computer systems

DAY 01(8:30 AM - 4:30 PM)

08.30 AM - 09.00 AM: Registration

09.00 AM: Session Start

Day 1 – Lectures and Workshop Exercises

Module 1: Historical background and data integrity definitions

  • Data integrity and patient safety/product efficacy
  • The evolution of GxP regulations – driven by both criminal activity and honest mistakes
  • The US FDA’s debarment policy
  • Evolution of data integrity guidances
  • Introduction to GAMP 5
  • Early data integrity cases

Module 2: Regulatory expectations

  • ALCOA and ALCOA+
  • Static and dynamic records
  • Essential elements of data governance
  • Non-conformance trends
  • Data integrity controls
  • Data integrity risks in sample analysis and production
  • Investigating data integrity problems
  • Metadata, audit trails and audit trail review
  • Exercise: deliberate falsification

Module 3: Data integrity risk assessment

  • Quality risk management: ICH Q9
  • Risk management process
  • Approaching a data integrity risk assessment
  • Controlling risk in computerised systems
  • Configuration and life cycle management
  • Operating system and application software considerations

Module 4: Computerised systems

  • Audit trails, access controls and user permissions
  • Exercise: reviewing records for data integrity violations
  • Excel spreadsheets
  • Introduction to computerised data system validation

Module 5: Day 1 conclusions

  • Extracts from regulatory enforcement letters
  • Addressing data integrity problems

DAY 02(8:30 AM - 4:30 PM)

Day 2 - Lectures and Workshop Exercises

Module 6: Managing computerised data systems

  • Guidance
  • 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • Life cycle management and risk assessment
  • Supplier assessment

Module 7: Computerised system validation

  • Validation planning
  • Policy
  • Plans
  • Documentation
  • System description
  • Introduction to software testing

Module 8: Conducting a data integrity audit

  • Planning the audit
  • Conducting the audit
  • Policies, procedures, practices
  • Training
  • Quality culture
  • Evaluating quality risk
  • Mitigating data integrity risks

Module 9: Managing client audits and regulatory inspections

  • The importance of data integrity risk assessments/action plans
  • The audit/inspection process
  • Client audits
  • Confidentiality
  • Result checking and reporting
  • Regulatory inspections
  • Behaviour during inspection
  • Responding to non-conformance observations
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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