Greetings!
What may seem like a minor oversight can quickly become a major compliance concern during an FDA inspection.
Data integrity remains one of the most frequently cited issues in regulatory observations and warning letters because regulators rely on data to verify that products are safe, effective, and consistently manufactured. When the integrity of that data is questioned, so is the integrity of the entire quality system.
Join AAPS Pharma for an upcoming workshop that takes a practical look at how data integrity failures occur, what regulators expect, and how organizations can build stronger controls to prevent compliance risks before they arise.
In this session, you will learn how to:
- Apply the ALCOA+ principles in real-world operations
- Recognize common causes of data integrity failures
- Understand FDA expectations and inspection focus areas
- Review real warning letters and Form 483 observations
- Identify compliance gaps within your own processes
- Build data integrity into systems, procedures, and daily practices
Whether you work in Quality Assurance, Regulatory Affairs, Compliance, Quality Control, Manufacturing, or Data Management, this workshop will provide practical insights that can help strengthen compliance and inspection readiness.
About the Instructor Jason Chu, Director of Operations at AAPS, brings extensive experience in GMP compliance, Quality Control, Analytical R&D, laboratory investigations, process validation, and audit support. Having worked directly in regulated environments and supported Health Canada and FDA inspections, he offers practical insights that go beyond theory and into real-world application.
All participants will receive a Certificate of Attendance upon completion of the workshop. Data integrity is not just about compliance. It is about confidence in every decision your organization makes.
Reserve your spot today. |
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