Data Integrity Workshop

Dive into the critical aspects of data integrity within the pharmaceutical industry in this intensive one-day workshop.

Gain a deep understanding of regulatory expectations, practical challenges, and strategic solutions essential to ensure data accuracy, security, and compliance.

This program seamlessly blends theoretical foundations with practical insights, empowering professionals to effectively manage and safeguard data throughout its lifecycle.

Program Highlights

Introduction & Overview
Understand the fundamentals of data integrity, its significance, and regulatory expectations.
Regulatory Frameworks & Guidelines
Explore the roles of key agencies such as the FDA, EMA, MHRA and get acquainted with essential regulations like 21 CFR Part 11, CGMP, as well as global standards including ISO guidelines.
Core Principles of Data Integrity
Master the ALCOA Fundamentals – Attributable, Legible, Contemporaneous, Original, Accurate – along with extended principles: Complete, Consistent, Enduring, and Available.
Data Lifecycle Management in Pharmaceutical Processes
Learn the critical stages of data handling: collection, processing, storage, and retrieval.
Challenges, Best Practices & Emerging Trends
Analyze digital system complexities, human factors, cybersecurity risks, audit trail gaps, and explore case studies that highlight remediation strategies and the impact of emerging technologies such as AI and Blockchain.

What You Will Learn

Comprehensive Knowledge
Develop a thorough understanding of data integrity principles and their application in the pharmaceutical industry.
Regulatory Compliance
Learn to navigate and adhere to regulatory frameworks and guidelines.
Lifecycle Mastery
Gain the skills needed to manage the complete data lifecycle from generation to archiving.
Problem-Solving
Identify and mitigate common challenges including cybersecurity threats and human error.
Future-Forward Thinking
Explore advanced technologies and emerging trends that are set to shape the future of data integrity practices.

Who Should Attend?

This workshop is ideal for:

Quality Assurance Professionals
Regulatory Affairs Specialists
Laboratory Personnel
IT Experts
Anyone involved in managing data integrity within the pharmaceutical industry

Meet Our Instructor

Dr. Loice C. Kikwai is a pharmaceutical regulatory expert with 15+ years of experience in EMA, FDA, WHO, and ICH guidelines, specializing in generic drugs and bioequivalence. She has consulted globally, reviewed data for ANDAs and INDs, and authored industry guidance on clinical pharmacokinetic studies.