Data Integrity Badge
Why Data Integrity? To state the obvious, if data is not accurate, consistent and complete, you not only run the risk of reglatory findings, but patient’s could be at risk. The classes in this badge will prepare you with an understanding of data preparation, documentation, management and strategy.
Who Should Enroll? The Data Integrity Badge is designed for those who are familiar with Good Documentation Practices. Those involved in GMP operations, R&D, Clinical Trials, and anyone who handles any data should enroll in this program. This Badge is also an exceptional resource for those involved in finding and investigating data integrity failures.
What Will I Learn? The Data Integrity Badge builds upon the concepts of Good Documentation Practices, and teaches you how to increase the assurance of data integrity across your GMP systems. This Badge includes many case studies, 'how to' find data integrity breaches, 'how to' investigate breaches, and 'how to' build a culture of data integrity ownership.
Digital Badge? Once you successfully complete the on-demand program, you will be awarded a Certificate of Completion and a Digital Badge that you can share on LinkedIn!
Meet Your Expert Instructors!
The Curriculum
Data Integrity Badge: 6 Classes. 11 Videos. ~6.3 hours [0.63CEU]
Class 1: How Data Integrity Became a Concern - Interview
Instructor: Brent Conatser (Elanco, former FDA)
Learning Objectives:
1. Understand what drove illegal activity during the Generic Drug Scandal
2. Understand how Data Integrity became a critical concern for regulators, investors, employees
Class 2a: Introduction to Data Integrity - Definitions
Instructor: Jennifer Ahearn (ESi, former FDA)
Learning Objectives:
1. What does “Data Integrity” mean?
2. Understand the principles of ALCOA Plus
Class 2b: Introduction to Data Integrity - Overview
Instructor: Jennifer Ahearn (ESi, former FDA)
Learning Objectives:
1. Understand examples of data integrity breaches
2. Recognize the implications of data integrity breaches
Class 2c: Introduction to Data Integrity - Assurance
Instructor: Jennifer Ahearn (ESi, former FDA)
Learning Objectives:
1. Deeper understanding of what is included in “Data”
2. Expectations for Data Integrity failure investigations
Class 3a: Data Integrity for Electronic Records - Background
Instructor: Jennifer Ahearn (ESi, former FDA)
Learning Objectives:
1. Understand the complexities of electronic data management
2. Recognize that your data is one of the greatest assets your company owns
Class 3b: Data Integrity for Electronic Records - In Operations
Instructor: Jennifer Ahearn (ESi, former FDA)
Learning Objectives:
1. Data Integrity assurance should be commensurate with the risk.
2. Understand what is meant by data flow, and how to use that knowledge.
3. Identify critical steps in your operations that require increased data integrity assurance.
Class 4a: How to Find Data Integrity Issues - Part 1
Instructor: Chris Chaney (Elanco) and Brent Conatser (Elanco, former FDA)
Learning Objectives:
1. Dive into how to find data integrity breaches during a Data Integrity Audit
2. Learn how to take a systems approach to the audit
3. Understand what to verify
Class 4b: How to Find Data Integrity Issues - Part 2
Instructor: Chris Chaney (Elanco) and Brent Conatser (Elanco, former FDA)
Learning Objectives:
1. Identify data integrity concerns while conducting GMP audits
2. Learn how to respond to what is found
Class 5: Data Integrity Governance and Corporate Culture
Instructor: Jennifer Ahearn (ESi, former FDA)
Learning Objectives:
1. Understand the Role of Culture on the ability to assure data integrity.
2. Identify ways to audit your systems and processes (including technology and people) for data integrity points of failure (reactively and proactively)
Class 6a: Data Integrity Case Study - Setting the Stage
Instructor: April Muir (Thermo Fisher Scientific) and Marla Phillips (Pathway, former Merck)
Learning Objectives: To discuss a case study for students to work on
Class 6b: Data Integrity Case Study - Analysis
Instructor: April Muir (Thermo Fisher Scientific) and Marla Phillips (Pathway, former Merck)
Learning Objectives: Learn to identify data integrity breaches through Case Study Analysis
Pricing for On-Demand Badge:
How Will You Access the Course?
All Badge Courses are on-demand and are accessed through Pathway’s Learning Management System - Canvas.
You will receive an email invitation from Canvas (notifications@instructure.com).
You will create a Canvas log-in used for all Badges you take through Pathway.
In Canvas, you will complete all classes in sequential order. After completing a quiz at the end of each class, the next class will be made available to you.
After completing your course, you will receive your Certificate of Completion, which you can share as a Digital Badge on LinkedIn!
Interested in More? Quality Operations Forum
for Year Round Learning
If you are a Site or Corporate Quality Professional, you are invited to join our Quality Operations Forum.
You will have many opportunities throughout the year to learn from your global peers, Chief Quality Officers and experts from our industry and beyond.
The purpose of the forum is to support you in proactively implementing successful practices gained through a vibrant network of global peers collaboratively addressing contemporary and complex challenges.
60+ World Cafe and External Intelligence meetings throughout the year are included!
Questions? Please contact Michelle Rich, our Director of Corporate Programs with any questions you might have.