Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements

Overview:

This webinar, Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements, provides a comprehensive overview of data integrity principles, regulatory expectations, and compliance strategies in pharmaceutical and clinical environments.

Participants will gain insights into the ALCOA+ framework, common data integrity risks, and best practices for ensuring reliable, accurate, and secure data.

The session will cover key regulatory guidelines from the FDA, EMA, and MHRA, with a focus on electronic vs. paper-based data controls, audit readiness, and lessons learned from real-world enforcement actions. Attendees will leave with practical strategies to strengthen data governance, prevent compliance violations, and maintain trust in regulated data processes.

Why you should Attend:

Participants should take this training to gain a clear understanding of regulatory expectations for data integrity in GMP and GCP environments and to ensure compliance with FDA, EMA, and MHRA requirements. Learn how to identify and mitigate data integrity risks that can lead to regulatory violations, costly remediation efforts, and potential reputational damage.

Strengthen knowledge of the ALCOA+ principles, implement effective data governance strategies, and prepare for regulatory inspections with confidence. Stay ahead of evolving compliance requirements and enhance professional expertise in maintaining accurate, reliable, and audit-ready data across pharmaceutical manufacturing and clinical research operations.

Areas Covered in the Session:

• Introduction (10 minutes)
  
  • Welcome and Speaker Introduction (2 minutes)
    
    • Brief introduction of the speaker and expertise
    • Overview of the session objectives
  • Importance of Data Integrity in GMP and GCP (3 minutes)
    
    • Definition of data integrity
    • Why it is critical in Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP)
    • Impact of data integrity failures on product safety, efficacy, and regulatory compliance
  • Regulatory Framework Overview (5 minutes)
    
    • Key global regulatory agencies:
      
      • FDA (21 CFR Part 11, Data Integrity and Compliance with CGMP Guidance)
      • EMA (EudraLex Volume 4, Annex 11 & Annex 15)
      • MHRA (Guidance on GxP Data Integrity)
    • Comparison of expectations across agencies
• Core Principles of Data Integrity (15 minutes)
  
  • The ALCOA+ Principles (7 minutes)
  • Attributable
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • + (Complete, Consistent, Enduring, Available)
• Data Integrity Risks and Challenges (8 minutes)
  
  • Common data integrity failures in GMP and GCP environments
  • Case studies of regulatory actions due to data integrity violations
  • Factors contributing to poor data integrity (human errors, lack of controls, system vulnerabilities
• Compliance Strategies and Best Practices (20 minutes)
  
  • Policies and Procedures for Ensuring Data Integrity (5 minutes)
    
    • Standard Operating Procedures (SOPs) and training requirements
    • Roles and responsibilities in maintaining data integrity
  • Electronic vs. Paper-Based Data Integrity Controls (5 minutes)
    
    • 21 CFR Part 11 and Annex 11 requirements for electronic records and signatures
    • Secure and validated systems for electronic data capture
    • Data backup, audit trails, and access controls
  • Data Governance and Quality Systems (5 minutes)
    
    • Implementing robust data governance frameworks
    • Data review processes and oversight mechanisms
  • Regulatory Inspections and Audit Readiness (5 minutes)
    
    • How regulatory agencies assess data integrity compliance
    • Preparing for inspections: documentation and corrective actions
• Case Studies and Lessons Learned (10 minutes)
  
  • Real-World Regulatory Findings and Lessons Learned (5 minutes)
    
    • Examples of regulatory enforcement actions (FDA warning letters, MHRA/EMA findings)
    • Key takeaways from industry failures
  • Interactive Q&A Session (5 minutes)
    
    • Open floor for participant questions
    • Addressing common concerns and challenges

Who Will Benefit:

• Quality Assurance (QA)
• Quality Control (QC)
• Regulatory Affairs
• Clinical Research and Development
• Manufacturing Operations
• Data Management
• Compliance and Auditing
• IT and Computer System Validation (CSV)
• Research and Development (R&D)
• Pharmacovigilance
• Laboratory Management
• Supply Chain and Logistics
• Legal and Risk Management
• Training and Development
• Executive Leadership and Management