Data integrity is a fundamental requirement in Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) environments, ensuring the reliability, accuracy, and security of data throughout the product lifecycle. Regulatory agencies such as the FDA, EMA, and MHRA have intensified their focus on data integrity compliance, issuing guidance and enforcement actions against companies that fail to maintain trustworthy records. With the increasing use of electronic data systems and automation, organizations must implement robust controls to prevent data manipulation, unauthorized access, and compliance failures. This training provides participants with a thorough understanding of global regulatory expectations, practical strategies for maintaining data integrity, and insights into industry best practices to mitigate compliance risks.
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.
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:
- Understand FDA, EMA, and MHRA expectations for data integrity
- Identify and mitigate common compliance risks
- Strengthen ALCOA+ knowledge and implementation
- Develop SOPs and governance systems to support data reliability
- Gain real-world insights from regulatory enforcement case studies
- Be inspection-ready with best practices in documentation and oversight
Course Content
- Introduction
- Welcome and Speaker Introduction
- Brief introduction of the speaker and expertise
- Overview of the session objectives
- Importance of Data Integrity in GMP and GCP
- 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
- 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
- The ALCOA+ Principles
- Attributable, Legible, Contemporaneous, Original, Accurate
- + (Complete, Consistent, Enduring, Available)
- Data Integrity Risks and Challenges
- 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
- Policies and Procedures for Ensuring Data Integrity
- Standard Operating Procedures (SOPs) and training requirements
- Roles and responsibilities in maintaining data integrity
- Electronic vs. Paper-Based Data Integrity Controls
- 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
- Implementing robust data governance frameworks
- Data review processes and oversight mechanisms
- Regulatory Inspections and Audit Readiness
- How regulatory agencies assess data integrity compliance
- Preparing for inspections: documentation and corrective actions
- Case Studies and Lessons Learned
- Real-World Regulatory Findings and Lessons Learned
- Examples of regulatory enforcement actions (FDA warning letters, MHRA/EMA findings)
- Key takeaways from industry failures
- Interactive Q&A Session
- Open floor for participant questions
- Addressing common concerns and challenges
Speaker
Charles Paul is an instructional designer and management consultant with over 30 years experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product OTC industries.Who Should Attend
- Quality Departments
- Production Departments
- Compliance Departments
- Engineering Departments
- R & D Departments
- IT Departments
- Management - essentially everyone in the organization who is tasked with creating or reviewing procedures
