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!

 

Attention Corporate Member Employees:  You have free access to this Badge.  Please login to the Corporate Member website to register, and feel free to contact Michelle.Rich@Pathway4PH.org if you need any help.

Interested in Corporate Membership where 100% of your employees can have unlimited access to over 120 courses and badges? Learn More!

 

Meet Your Expert Instructors!

Featured
Jennifer Ahearn
Jennifer Ahearn

Owner/CEO, GMPACT LLC

— 25+ years experience in FDA and Industry
— Former FDA Office of Criminal Investigations Technical Liaison, working on criminal investigations with FDA and FBI agents
— Provided testimony in cases from FDA’s Office of General Council, Department of Justice, US Attorney’s Office and CDER
— Former Senior Forensic Scientist, Georgia Bureau of Investigation

Christopher Chaney
Christopher Chaney

Quality Assurance Auditor, Elanco

— 26+ years industry experience, spanning laboratory operations, manufacturingsciences and technical services, microbiology, and quality assurance
— Responsible for auditing internal manufacturing sites, affiliates, contract manufacturers, suppliers and GMP service providers
— Conduct Due Diligence audits for business acquisitions and partnerships

Brent Conatser
Brent Conatser

Lead Quality Advisor, Elanco

— 39 years experience in FDA and indsutry
— Served as an FDA investigator and compliance officer during the Generic Drug Scandal
— Former Janssen Manager of Regulatory Affairs in Belgium, and Associate Director of Worldwide Compliance for Pfizer
— Joined Eli Lilly in 2002 in Quality Assurance, which then split off Elanco in 2015. Served in External Intelligence and was a Lead Quality Advisor

April Muir, M.S.
April Muir, M.S.

Quality Director - Data Integrity Officer

— 25+ years of industry experience
— Leads global data integrity work across policies, procedures, escalation, deviations and training
— Expert in analytical development, methods and systems
— Became a Manager of Quality Assurance for Thermo Fisher (now owner of Patheon), and led auditing, batch release, quality control data review and training
— Began as a research chemist at Cardinal Health

Marla Phillips, Ph.D.
Marla Phillips, Ph.D.

CEO and President, Pathway for Patient Health

— 28+ years of industry experience
— Former Merck, Head of Quality for North Carolina Facility
— 14.5 years of experience in leading initiatives with global regulators and industry experts across pharma, device, combination products and artificial intelligence
— Deep understanding of what drives human behavior and how to affect exceptional outcomes

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 - $300

 

Attention Corporate Member Employees:  You have free access to this Badge.  Please login to the Corporate Member website to register, and feel free to contact Michelle.Rich@Pathway4PH.org if you need any help.

Interested in Corporate Membership where 100% of your employees can have unlimited access to over 120 courses and badges? Learn More!

How Will You Access the Course?

All Badge Courses are on-demand and are accessed through Pathway’s Learning Management System - Canvas.

  1. You will receive an email invitation from Canvas (notifications@instructure.com).

  2. You will create a Canvas log-in used for all Badges you take through Pathway.

  3. 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.

  4. 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.