Learning Paths
Core
- The Fundamentals of GxP in a Regulated Environment
- The Fundamentals of Quality Management Systems – Pharma
- The Fundamentals of Data Integrity
Build
- 21 CFR Part 11 – An Introduction
- 21 CFR Part 11 – Electronic Signatures
- General Inspection Readiness
- Data Integrity Awareness: ALCOA+
Refresh
- GxP Hot Topics: Cybersecurity Refresher Course
- 1930 – Lubeck BCG Vaccine
- 1938 – Sulfanilamide, the Elixir of Death
- 1955 – The Polio Vaccine – The Cutter Incident
- 2005 Able Laboratories Scandal
- Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video]
- Jim the Horse Tetanus Scandal
- Putting Patients First: The Power of Speaking Up for Patient Safety
Good Manufacturing Practices (cGMP) - Beginner
1955 – The Polio Vaccine – The Cutter Incident
3 mins
Data Integrity (ALCOA)
Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video]
1 min