Successful completion provides learners with a dated, traceable and downloadable certificate for the course :
Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.
GxP refers to a set of quality and compliance guidelines applied across the pharmaceutical, biotechnology, and other life sciences sectors. These guidelines ensure that products are safe, effective, and meet regulatory expectations from development to delivery.
Whether you’re in manufacturing, clinical trials, QA, or distribution, this course provides a clear and practical introduction to the key GxP principles shaping your industry.
This course is ideal for professionals working in or entering the pharmaceutical, biotechnology, or life sciences sectors. It’s a strong foundation for new hires, trainees, or anyone preparing for audits or regulatory inspections.
Built by a team of seasoned Regulatory Affairs professionals, this course is led by experts with qualifications from Northeastern University, Boston, and real-world experience bridging regulatory theory and practice.
By the end of this course, you will be able to:
Understand the core principles of GxP and their role in regulatory compliance.
Differentiate between GxP and current GxP (cGxP) standards.
Identify how each major GxP area (GMP, GLP, GDP, GCP, GDocP) applies to different stages of the product lifecycle.
Speak confidently about GxP in audits, inspections, and internal training.
Lesson 1: Introduction to GxP guidelines
Lesson 2: The many faces of GxP
Lesson 3: Good Manufacturing Practice (GMP)
Lesson 4: Good Laboratory Practice (GLP)
Lesson 5: Good Distribution Practice (GDP)
Lesson 6: Good Clinical Practice (GCP)
Lesson 7: Good Documentation Practice (GDocP)
Conclusion
Glossary
Evaluation
$95.00 / year
