Data Integrity (ALCOA)

Data Integrity Awareness: Health Authorities

Upon completion of this course, you will be able to explain the following concepts related to data integrity awareness and health authorities, health authority auditing, FDA and MHRA data integrity expectations, observations by health authority inspectors and recent examples of violations found in FDA warning letters.

CEU Credits: 0.1

Course Code: ELM-151

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Program Introduction

Course Introduction

Learning Objectives

Overview: Data Integrity Awareness

Who Should Take This Program?

Health Authority Auditing

FDA on Data Integrity – Part 1

FDA on Data Integrity – Part 2

Knowledge Check 1

MHRA on Data Integrity

Observations by Health Authority Inspectors

Data Integrity Issues Can Happen Anywhere

Knowledge Check 2

Recent Inspection Findings

Example 1: Hanlim Pharm Co FDA Warning Letter

Example 2: Bayer Pharma AG FDA Warning Letter

Example 3: IDT Australia Ltd. FDA Warning Letter

Example 4: Tai Heng Industry Co. FDA Warning Letter

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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