Greetings!
Data integrity remains one of the most critical pillars of quality, compliance, and patient safety within regulated industries. Regulatory agencies including the FDA continue to place significant emphasis on data governance, with data integrity deficiencies frequently cited in warning letters, inspection observations, and enforcement actions.
To help professionals better understand and address these expectations, AAPS Pharma is pleased to present an upcoming workshop focused on the principles, risks, and practical application of data integrity in regulated environments.
During this session, participants will gain a comprehensive understanding of data integrity fundamentals, regulatory expectations, and common causes of data integrity failures. The workshop will also explore the ALCOA+ principles, FDA requirements, and real-world examples drawn from warning letters and Form 483 observations.
Attendees will learn how to: • Understand the principles and importance of data integrity • Evaluate data integrity compliance within their organizations • Identify common root causes of data integrity failures • Interpret FDA expectations and regulatory requirements • Analyze warning letters and inspection findings related to data integrity • Design systems and processes that support data integrity by design
This workshop is particularly relevant for professionals working in Quality Assurance, Regulatory Affairs, Compliance, Quality Control, Manufacturing, and data management functions across pharmaceutical, food, cannabis, and other regulated industries.
About the Instructor The workshop will be led by Jason Chu, Director of Operations at AAPS.
Jason brings extensive industry experience spanning Quality Control, Analytical Research & Development, GMP compliance, laboratory investigations, process validation, audit response, and corporate training. Prior to joining AAPS, he held several technical and compliance-focused positions at Apotex Inc., including Analytical Research & Development Chemist, Quality Control Chemist, Designated Compliance Coordinator, and Subject Matter Expert supporting Health Canada and FDA audits.
In addition to his industry experience, Jason has delivered training on GMP regulations, health and safety, WHMIS, laboratory operations, and data integrity. His background combines hands-on technical expertise with a practical understanding of regulatory expectations, making this session particularly valuable for professionals seeking real-world compliance insights.
All participants will receive a Certificate of Attendance upon completion of the workshop.
Early Bird Offer Register by June 15 and receive 20% off registration using discount code: SAVE20
We look forward to welcoming you to this timely and practical discussion on one of the most important compliance topics facing regulated organizations today. |
No comments:
Post a Comment