Decoding FDA's 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping

Overview:

This webinar, Decoding FDA's 21 CFR Part 11 and EU Annex 11: Ensuring Compliance in Electronic Recordkeeping, provides a comprehensive understanding of regulatory requirements for electronic records and electronic signatures in the pharmaceutical, biotechnology, and medical device industries.

Participants will explore the core principles of both FDA 21 CFR Part 11 and EU Annex 11, including system validation, audit trails, data integrity, and cybersecurity.

The session will also cover compliance strategies, best practices, and common pitfalls that organizations face when managing electronic recordkeeping systems. Real-world case studies and recent regulatory enforcement actions will be examined to provide practical insights into maintaining compliance and preparing for regulatory inspections.

Why you should Attend:

Participants should attend this training to gain a clear and practical understanding of the regulatory requirements for electronic recordkeeping under FDA's 21 CFR Part 11 and EU Annex 11. Ensuring compliance with these regulations is essential for maintaining data integrity, avoiding regulatory penalties, and safeguarding electronic records in pharmaceutical, biotechnology, and medical device industries.

This session will equip attendees with best practices for system validation, audit trails, access controls, and cybersecurity measures to strengthen compliance frameworks. By learning from real-world case studies and recent regulatory enforcement actions, participants will be better prepared to mitigate risks, enhance electronic record management, and successfully navigate regulatory inspections.

Areas Covered in the Session:

• Introduction to Electronic Record Compliance (10 minutes)
  
  • Welcome and Speaker Introduction (2 minutes)
    
    • Introduction of the speaker and expertise in regulatory compliance
    • Overview of the session objectives
  • Importance of Electronic Record Compliance (3 minutes)
    
    • Transition from paper-based to electronic recordkeeping
    • The role of 21 CFR Part 11 and EU Annex 11 in ensuring data integrity and security
    • Consequences of non-compliance
  • Regulatory Overview: FDA 21 CFR Part 11 vs. EU Annex 11 (5 minutes)
    
    • Scope and applicability of both regulations
    • Key similarities and differences
    • How these regulations impact pharmaceutical, biotech, and medical device industries
• Key Requirements of 21 CFR Part 11 and Annex 11 (20 minutes)
  
  • Core Principles of 21 CFR Part 11 (10 minutes)
    
    • Electronic Records and Electronic Signatures
    • Validation of Electronic Systems
    • Audit Trails and Data Integrity
    • Access Controls and Security Measures
    • Legacy Systems and Hybrid Recordkeeping
  • Core Principles of EU Annex 11 (10 minutes)
    
    • Risk-Based Approach to Electronic Record Compliance
    • System Validation and Supplier Management
    • Data Management and Archiving Requirements
    • IT Governance and Business Continuity
    • Alignment with Good Automated Manufacturing Practice (GAMP 5)
• Compliance Strategies and Best Practices (20 minutes)
  
  • Validation and Qualification of Electronic Systems (5 minutes)
    
    • Developing a validation plan in accordance with regulatory expectations
    • Risk-based validation approaches and documentation requirements
  • Ensuring Data Integrity and Audit Readiness (5 minutes)
    
    • Implementing audit trails and controls to detect unauthorized changes
    • Periodic system reviews and compliance monitoring
  • Access Control and Cybersecurity Considerations (5 minutes)
    
    • User authentication and electronic signatures
    • Role-based access and protection against cybersecurity threats
  • Preparing for Regulatory Inspections and Avoiding Common Pitfalls (5 minutes)
    
    • What inspectors look for in electronic recordkeeping systems
    • Case studies of regulatory enforcement actions and lessons learned
• Case Studies and Practical Insights (5 minutes)
  
  • Regulatory Findings and Real-World Compliance Challenges (5 minutes)
    
    • Review of recent FDA warning letters and EU regulatory actions related to Part 11 and Annex 11
    • Key takeaways from compliance failures

Who Will Benefit:

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