In today's pharmaceutical landscape, data integrity has emerged as a critical aspect of regulatory inspections, with far-reaching consequences for both manufacturers and regulatory agencies. Maintaining data integrity is not just a regulatory expectation; it is vital for ensuring product quality, patient safety, and the overall reputation of pharmaceutical organizations.
In this transformative 2-day course, we will equip you with the knowledge and skills to navigate the complex world of data integrity within the pharmaceutical industry. Our agenda is carefully curated to address the key areas of concern and provide you with practical insights and regulatory guidance.
Day 1 of the Data Integrity Excellence in Pharma Masterclass will delve into the historical background of data integrity, its definitions, and its critical role in ensuring patient safety and product efficacy. We will explore the evolution of GxP regulations, the impact of data integrity on regulatory enforcement, and the significance of early data integrity cases. Regulatory expectations, including ALCOA and ALCOA+ principles, static and dynamic records, and essential elements of data governance, will be thoroughly examined. We will also address data integrity risks in sample analysis and production, investigating data integrity problems, and the importance of metadata, audit trails, and audit trail review.
On Day 2, we will focus on managing computerized data systems, including compliance with regulatory guidelines such as 21 CFR Part 11, EU Annex 11, and GAMP 5. You will gain insights into computerized system validation, software testing, and conducting data integrity audits. We will discuss client audits, regulatory inspections, and effective response strategies for non-conformance observations.
The course will equip you with the knowledge and tools to effectively manage client audits and regulatory inspections, including evaluating quality risk, mitigating data integrity risks, and responding to non-conformance observations.
Understand the Significance of Data Integrity: Comprehend the concept of data integrity and its critical role in ensuring patient safety and product efficacy within the pharmaceutical industry.
Identify Causes of Data Integrity Breaches: Recognize the diverse factors that can contribute to data integrity breaches, such as human error, technological limitations, and inadequate processes.
Stay Updated on Regulatory Expectations: Acquire up-to-date knowledge of current regulatory expectations related to data integrity.
Manage Static and Dynamic Records: Differentiate between static and dynamic records and employ appropriate strategies for the retention and maintenance of each record type.
Categorize and Validate GxP Computerized Systems: Utilize the GAMP 5 framework to categorize GxP computerized systems and apply validation principles to ensure their compliance with regulatory requirements
Respond to Data Integrity Observations: Learn how to effectively respond to data integrity observations identified in inspection reports or audits
Prevent, Detect, and Remedy Data Integrity Problems: Gain practical knowledge and techniques to proactively prevent, detect, and remediate data integrity problems within the pharmaceutical environment
Promote Training and Quality Culture: Understand the pivotal role of training and quality culture in preventing data integrity breaches and avoiding regulatory enforcement actions
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s AnalyticalDivision and led a working group on continuing professional development until July 2016.
He has worked at a senior level in several companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes, including stability evaluation.
In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved managing the analytical and stability aspects of early and late-stage pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, root cause analysis and stability/stress studies.