Count Every Second Until the Event

2023-11-09 8:30

Course Overview

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.

Why join the event

Key takeaways of the program

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

Who Should Attend

An event precisely for you

Quality Assurance Personnel
Quality Assurance Personnel
Laboratory Managers
Laboratory Managers
Production Managers
Production Managers
IT/IS Managers and System Administrators
IT/IS Managers and System Administrators
Software Developers
Software Developers
Regulatory Affairs
Regulatory Affairs

The speaker

Meet your trainer

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.

Dr. Mark Powell

Dr. Mark Powell

Mark Powell Scientific Limited

The Curriculum

What you’ll get from this exclusive event

Fresh Content

Knowledge is only useful when it is relevant. This event is based on the latest research, best practices and industry information. As a result, we close events with a strong knowledge base that helps achieve same-day results.


Meet and collaborate with like-minded professionals across the globe. Grow your professional network, exchange ideas, and learn more about the industry with your own peers, together.


Experience comes with practice, and this event will guide you on the right path in becoming a well renowned expert in your field. You will learn through a combination of lecture-based content, real-life case studies, and a more hands-on experience.

Q&A Session

By joining this class, you will be given the opportunity to constantly engage with your peers and raise your concerns, questions, or doubts you may have pertaining to the subject. And, receive well-founded, well-thought-out answers to your every need by leading experts in the industry. 

sign up

Getting registered is easy!

Valid number
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.