Data Integrity Awareness: Health Authorities
Description:
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 – Part 1 | 1 min 15 secs |
| FDA on Data Integrity – 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 |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-151 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
This program is key to us when training our new hires and our experienced employees. Great job!
Understanding the regulatory perspective is a huge part of conveying the data integrity message.
Loved the recent inspection finding section, a very timely reminder for our entire team.
Take Data Integrity as an example. I love the material currently available for GMP people. I can assign it to my GMP people and it just saved me 200+ hours of development work – ROI met.
Related courses:
Laboratory Data Integrity
An Introduction to Data Integrity Awareness
Managing and Ensuring Data Integrity of E-Records within a Regulated Environment
21 CFR Part 11 – Electronic Records
Implementing Compliant Systems in the Cloud
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