Data Integrity Awareness: Health Authority Expectations


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.

Curriculum for this course:
Program Introduction
Course Introduction 1 min 01 secs
Learning Objectives 1 min 30 secs
Overview: Data Integrity Awareness 1 min 21 secs
Who Should Take This Program? 1 min 25 secs
Health Authority Auditing
FDA on Data Integrity โ€“ Part 1 1 min 15 secs
FDA on Data Integrity โ€“ Part 2 1 min 10 secs
Knowledge Check 1 1 min 10 secs
MHRA on Data Integrity 1 min 30 secs
Observations by Health Authority Inspectors 1 min 23 secs
Data Integrity Issues Can Happen Anywhere 1 min 24 secs
Knowledge Check 2 1 min 11 secs
Recent Inspection Findings
Example 1: Hanlim Pharm Co FDA Warning Letter 1 min 20 secs
Example 2: Bayer Pharma AG FDA Warning Letter 1 min 55 secs
Example 3: IDT Australia Ltd. FDA Warning Letter 1 min 55 secs
Example 4: Tai Heng Industry Co. FDA Warning Letter 1 min 39 secs
Final Assessment

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