Introduction to Data Integrity

This three-part virtual classroom-led series provides an introduction to Data Integrity and the ALCOA principles from a regulatory perspective, highlighting why the integrity of data matters to our patients, and that data integrity does not have to be yet another GMP burden if the fundamentals are properly understood from the patient’s perspective. 

Each of the three modules build in complexity, and the learner can proceed at their own pace, referencing regulations and guidance along the journey. Each module is followed by a final knowledge check.

What’s Included

  • DI 101

    In our first module, we provide an introduction to data integrity via the relevant fundamental GMP regulations, and explore expectations for “complete” records throughout the product lifecycle.

  • DI 102

    Our second module begins the ALCOA journey, focusing on the concepts of Attributability, Legibility and Contemporaneous record-keeping. Here we introduce tools to visualize DI from a regulatory perspective (e.g., the iceberg analogy).

  • DI 103

    In this module we complete our evaluation of ALCOA, by discussing the concepts Original and Accurate. This is the most complex module, touching on the concepts of Data Governance and Risk Management; envisioning the future of GMP Data Integrity expectations.

Introduction to Data Integrity
$50.00
One time

Join us in this three-part virtual instructor-led eLearning experience based in a virtual classroom setting. The course is comprised of approximately two hours of video led by Peter Baker, and three individual knowledge check examinations. Proceed at your own pace, and refer to regulatory guidance along the way for maximum benefit. Exclusive regulatory insights provided regularly throughout the year as new guidance drops in the form of FDA 483s and Warning Letters.

✓ One Year Subscription Membership
✓ Access to Exclusive Regulatory Insights
✓ Digital Badge Received Upon Successful Course Completion

✺ Frequently Asked Questions (FAQs) ✺

  • All of our training is instructor led (Peter Baker) in a virtual classroom-based setting. There are no slides, clicks or distractions along the way.

  • Each of the three modules is followed by a knowledge check examination. A score of 90% is required for each exam.

  • Any content questions should be sent to info@liveoakqa.com

  • This course is designed as an introduction to the ALCOA principles, and as an annual Data Integrity refresher.

  • This three-part modular series explores the ALCOA principles from a regulatory perspective. The goal is to empower employees to understand the why behind DI.

  • Definitely! We recommend reading the PIC/s Guide for Data Integrity as the course proceeds, for maximum empowerment!