Curriculum

Virtual Manufacturing (GCP)

Virtual manufacturers in the life sciences industry are companies that do not own or operate physical manufacturing facilities. They rely on CDMOs (Contract Development and Manufacturing Organizations) to manufacture their products and CROs (Contract Research Organizations) to conduct necessary clinical trials. By outsourcing these core activities, virtual manufacturers can focus on product development, research, and marketing, reducing overhead costs and accelerating time-to-market.

Learning Paths

Core

The Fundamentals of Good Clinical Practices (ICH E6 R2)
The Fundamentals of Good Pharmacovigilance Practices (GVP)
The Fundamentals of GxP in a Regulated Environment
The Fundamentals of Quality Management Systems – Pharma
The Fundamentals of Data Integrity

Build

How to Perform Supplier Qualification
Supplier Quality Management
Customer Complaint Handling
CAPA and Effectiveness Checks
General Inspection Readiness
How to Write Effective Standard Operating Procedures (SOPs)
ICH Q9 – Quality Risk Management
Recalls and Consent Decrees
Regulatory Submissions
Change Control: Core Concepts
Batch/Product Release
ICH E6 – Sponsor (Chapter 5) (R2)
GVP PSUR (Periodic Safety Update Reports)

Refresh

Good Clinical Practice Refresher Course
GxP Hot Topics: Cybersecurity Refresher Course
Good Documentation Practice Refresher Course
Data Integrity Refresher Course
Aligning Success KPIs and Quality Culture
Data Integrity Applies to Everyone in the Organization – ALCOA+ [Video]
How Self-Inspection Leads to Continuous Improvement
Ignoring Issues and the Repercussions That Can Follow

Accredited Courses

Fundamentals Series

The Fundamentals of Good Clinical Practices (ICH E6 R2)

20 mins

Basic

Accredited Courses

Good Pharmacovigilance Practices (GVP)

The Fundamentals of Good Pharmacovigilance Practices (GVP)

20 mins

Basic

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

Equipment Qualification

How to Perform Supplier Qualification

60 mins

Basic

Accredited Courses

Supplier Quality Management

Supplier Quality Management

15 mins

Intermediate

Accredited Courses

Customer Complaint Handling

15 mins

Basic

Accredited Courses

Good Documentation Practices (GDocP)

CAPA and Effectiveness Checks

20 mins

Intermediate

Accredited Courses

FDA Inspection Readiness (GMP Auditing)

General Inspection Readiness

20 mins

Basic

Accredited Courses

Good Documentation Practices (GDocP)

How to Write Effective Standard Operating Procedures (SOPs)

60 mins

Basic

Accredited Courses

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

ICH Q9 – Quality Risk Management

25 mins

Intermediate

Accredited Courses

Good Pharmacovigilance Practices (GVP)

Recalls and Consent Decrees

20 mins

Intermediate

Accredited Courses

Good Manufacturing Practices (cGMP) - Intermediate

Regulatory Submissions

15 mins

Intermediate

Accredited Courses

Change Control

Change Control: Core Concepts

20 mins

Intermediate

Accredited Courses

Good Manufacturing Practices (cGMP) - Intermediate

Batch/Product Release

15 mins

Intermediate

Accredited Courses

ICH E6

ICH E6 – Sponsor (Chapter 5) (R2)

15 mins

Intermediate

Accredited Courses

Good Pharmacovigilance Practices (GVP)

GVP PSUR (Periodic Safety Update Reports)

15 mins

Intermediate

Accredited Courses

Refresher Training

Good Clinical Practice Refresher Course

5 mins

Intermediate

Accredited Courses

Refresher Training

GxP Hot Topics: Cybersecurity Refresher Course

5 mins

Intermediate

Accredited Courses

Refresher Training

Good Documentation Practice Refresher Course

5 mins

Intermediate

Accredited Courses

Refresher Training

Data Integrity Refresher Course

5 mins

Intermediate

Microlearnings

Aligning Success KPIs and Quality Culture

1 min

Data Integrity (ALCOA)

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

1 min

FDA Inspection Readiness (GMP Auditing)

How Self-Inspection Leads to Continuous Improvement

3 mins

Basic

Microlearnings

Ignoring Issues and the Repercussions That Can Follow

1 min

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