GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry

A Comprehensive Review of the Latest MHRA Data Integrity Definitions and Guidances Including the FDA’s Most Recent Guidance

Data integrity is the cornerstone of pharmaceutical operations and the trust between companies, regulators, and patients. Lapses can range from simple miscalculations to intentional fabrication of data. Both FDA and European regulators have detected serious failures, leading to warning letters and new guidances.

In this webinar, we will examine the types of data integrity failures, how to detect them, and their root causes. We will review the MHRA GMP Data Integrity Definitions and Guidance, FDA guidance, as well as WHO and PIC/S positions. Attendees will learn tools to detect, measure, investigate, and remediate data integrity lapses, and how to build proactive systems that maintain compliance and trust.

Learning Benefits

• Understand MHRA GMP data integrity definitions and guidance
• Review FDA data integrity guidance and principles
• Apply Quality Risk Management to identify vulnerabilities
• Recognize tell-tale signs of data integrity issues
• Differentiate intentional vs unintentional failures
• Develop remediation plans to reduce risks
• Learn how regulatory agencies detect issues
• Integrate FDA and MHRA approaches into compliance programs

Regulations Covered

• EMEA Eudralex Volumes 1, 2, 3, 4, 9 (EU)
• US CFR 21 Parts 210, 211, and 600 series
• MHRA GMP Data Integrity Guidance (2015, 2016, 2018)
• FDA Data Integrity and Compliance with cGMP Guidance (2016)
• EMA, WHO, and PIC/S guidance (2016)
• ICH Q9 Quality Risk Management

Who Should Attend

• Quality Assurance & Quality Control personnel
• Supply Chain & Logistics Managers
• Regulatory Affairs Professionals
• Process Development Scientists
• IT and Senior Management
• Engineering staff and management
• Project Managers working in CMC