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

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements (Oct 7, 2025)" training has been added to ResearchAndMarkets.com's offering.

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.

Why You Should Attend:

Understand FDA, EMA, and MHRA expectations for data integrityIdentify and mitigate common compliance risksStrengthen ALCOA+ knowledge and implementationDevelop SOPs and governance systems to support data reliabilityGain real-world insights from regulatory enforcement case studiesBe inspection-ready with best practices in documentation and oversight

Who Should Attend:

Quality DepartmentsProduction DepartmentsCompliance DepartmentsEngineering DepartmentsR & D DepartmentsIT DepartmentsManagement - essentially everyone in the organization who is tasked with creating or reviewing procedures

Key Topics Covered:

IntroductionWelcome and Speaker IntroductionBrief introduction of the speaker and expertiseOverview of the session objectivesImportance of Data Integrity in GMP and GCPDefinition of data integrityWhy it is critical in Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP)Impact of data integrity failures on product safety, efficacy, and regulatory complianceRegulatory Framework OverviewKey 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 agenciesCore Principles of Data IntegrityThe ALCOA+ PrinciplesAttributable, Legible, Contemporaneous, Original, Accurate+ (Complete, Consistent, Enduring, Available)Data Integrity Risks and ChallengesCommon data integrity failures in GMP and GCP environmentsCase studies of regulatory actions due to data integrity violationsFactors contributing to poor data integrity (human errors, lack of controls, system vulnerabilities)Compliance Strategies and Best PracticesPolicies and Procedures for Ensuring Data IntegrityStandard Operating Procedures (SOPs) and training requirementsRoles and responsibilities in maintaining data integrityElectronic vs. Paper-Based Data Integrity Controls21 CFR Part 11 and Annex 11 requirements for electronic records and signaturesSecure and validated systems for electronic data captureData backup, audit trails, and access controlsData Governance and Quality SystemsImplementing robust data governance frameworksData review processes and oversight mechanismsRegulatory Inspections and Audit ReadinessHow regulatory agencies assess data integrity compliancePreparing for inspections: documentation and corrective actionsCase Studies and Lessons LearnedReal-World Regulatory Findings and Lessons LearnedExamples of regulatory enforcement actions (FDA warning letters, MHRA/EMA findings)Key takeaways from industry failuresInteractive Q&A SessionOpen floor for participant questionsAddressing 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.

For more information about this training visit https://www.researchandmarkets.com/r/ijqe58

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