Data Integrity Badge - Advanced

Welcome to the Data Integrity Badge.

Strong Recommendation: Please complete the Good Documentation Practices course before participating in this badge. The classes in this badge will prepare the learner with an understanding of data preparation, documentation, management and strategy. The Data Integrity Badge is considered an advanced badge that builds upon the principles of good documentation practices.

You will find each class listed below with the Learning Objectives, Instructor and link to the Course Content: video, slides, note-taking worksheets. We hope you enjoy this program!

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Certificate of Completion?

To earn a Certificate of Completion:

  1. Watch the videos on this page

  2. Use the note-taking worksheets available in each class

  3. Click the "Take the Certificate of Completion Quiz" button

  4. Complete quizzes related to each video

You'll have multiple attempts to pass each quiz if needed—our goal is for you to learn, not to be penalized. Upon successful completion of the program, you will receive a Certificate of Completion.

Technical Support

If you need technical assistance, or have feedback related to these classes, please complete the following form which will be sent immediately to our Pathway Team. You will be contacted within 1 business day regarding questions you have: Technical Support Form

Course Evaluation

Please complete an evaluation of any course you take through this Corporate Membership Site. Your insight is invaluable, and will help ensure the content is accurate, up-to-date and relevant: Course Evaluation Form

 

Data Integrity Badge: 6 Classes. 11 Videos. ~6.3 hours [0.63 CEU]

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Class 1: How Data Integrity Became a Concern - Interview
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

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Class 2a: Introduction to Data Integrity - Definitions
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

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Class 2b: Introduction to Data Integrity - Overview
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

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Class 2c: Introduction to Data Integrity - Assurance
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

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Class 3a: Data Integrity for Electronic Records - Background
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

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Class 3b: Data Integrity for Electronic Records - In Operations
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.

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Class 4a: How to Find Data Integrity Issues - Part 1
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

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Class 4b: How to Find Data Integrity Issues - Part 2
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

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Class 5: Data Integrity Governance and Corporate Culture
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)

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Class 6a: Data Integrity Case Study - Setting the Stage
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

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Class 6b: Data Integrity Case Study - Analysis
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

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