Introduction to Current Good Practice (CGXP)

Entering or working within a GxP-regulated environment requires more than familiarity with a single guideline. It demands an understanding of how quality and compliance frameworks connect across the entire product lifecycle. This introductory course provides that foundation, covering the principles, regulatory bodies, and key disciplines (GMP, GLP, GCP, GDP, and GDocP) that define Current Good Practices (cGxP) in life sciences.

Developed by Regulatory Affairs experts with qualifications from Northeastern University, Boston, this course equips learners with the foundational knowledge to navigate GxP-regulated environments with confidence.

🚀 Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

✅ Who Should Enroll?

• Newcomers and professionals transitioning into GxP-regulated environments
• Quality, regulatory, compliance, laboratory, or manufacturing staff
• Regulatory affairs and QA professionals seeking a consolidated cGxP overview
• Training and HR teams building onboarding programs for regulated industries

 
🎯 What You’ll Learn?

• The purpose and scope of cGxP across the product lifecycle
• Key regulatory bodies and the disciplines they govern (GMP, GLP, GCP, GDP, GDocP)
• Non-compliance risks and how to build effective compliance management systems
• Data integrity and good documentation practices within a cGxP framework
• cGxP implementation and validation readiness essentials

Curriculum

Introduction

Lesson 1: An Understanding to cGxP

• What is cGxP?
• Impact of cGxP

Lesson 2: Regulatory bodies for Pharmaceutical Industry

• Key GxPs in Pharmaceutical Industry

Lesson 3: Non-Compliance: A Major Obstacle

• Challenges in Compliance Management
• A RoadMap For Building an Effective and Efficient Compliance Management System
• Internal Initiatives

Lesson 4: Meeting and Maintaining the Standards Required for Good Practices in Pharma

Lesson 5: The Impact of Covid-19 on Biologics Regulations

• Role of MHRA
• Good Clinical Practice
• Good Laboratory Practice Compliance

Lesson 6: Training in Good Data and Record Management

• Good Documentation Practices

Lesson 7: Designing and Validating systems to Assure Data Quality and Reliability

• Validation to Assure Good Documentation Practices for Electronic Data
• User Involvement
• Configuration and Design Controls

Lesson 8: Data Life Cycle

• SOPs and Training
• Managing Data and Records Throughout the Data Life Cycle
• Data Collection and Recording

Lesson 9: Implementation of cGxP

• GxP Readiness Checklist
• Prepare for Your Validation Process

Conclusion

Glossary

Quiz