Curriculum

GxP New Hire

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

Accredited Courses

Fundamentals Series

The Fundamentals of GxP in a Regulated Environment

20 mins

Basic

Accredited Courses

Fundamentals Series

The Fundamentals of Quality Management Systems – Pharma

15 mins

Basic

Accredited Courses

Fundamentals Series

The Fundamentals of Data Integrity

10 mins

Basic

Accredited Courses

21 CFR Part 11

21 CFR Part 11 – An Introduction

15 mins

Intermediate

Accredited Courses

21 CFR Part 11

21 CFR Part 11 – Electronic Signatures

45 mins

Advanced

Accredited Courses

FDA Inspection Readiness (GMP Auditing)

General Inspection Readiness

20 mins

Basic

Accredited Courses

Data Integrity (ALCOA)

Data Integrity Awareness: ALCOA+

15 mins

Basic

Accredited Courses

Refresher Training

GxP Hot Topics: Cybersecurity Refresher Course

5 mins

Intermediate

Good Manufacturing Practices (cGMP) - Beginner

1930 – Lubeck BCG Vaccine

1 min

Good Manufacturing Practices (cGMP) - Beginner

1938 – Sulfanilamide, the Elixir of Death

3 mins

Good Manufacturing Practices (cGMP) - Beginner

1955 – The Polio Vaccine – The Cutter Incident

3 mins

Good Manufacturing Practices (cGMP) - Beginner

2005 Able Laboratories Scandal

1 min

Data Integrity (ALCOA)

Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video]

1 min

Good Manufacturing Practices (cGMP) - Beginner

Jim the Horse Tetanus Scandal

3 mins

Microlearnings

Putting Patients First: The Power of Speaking Up for Patient Safety

1 min

Related Curriculum

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