Introduction to Current Good Practice (CGXP)

current good practice cgxp (1)

Duration :


1 hour(s)

Skill level:




Final exam:


Certificate of Completion:


CEU / CPD Accreditation:



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.


The quality, efficacy, and safety of medicinal products are assured by employing guidelines appropriate for each stage of the manufacturing and distribution process. Current Good Practice (cGxP) is a set of such guidelines which have been put together by regulatory agencies such as WHO, EU, FDA, etc. This course helps participants understand the concept of cGxP, highlighting the advantage that it presents. You will also learn about non-compliance which is a major threat to the production of high-quality products. Finally, you get to see how regulatory bodies help to enforce these guidelines with inspections, audits, sanctions, and denial of marketing authorization.


In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.






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
  • Example Consideration
  • Data Processing
  • Example Considerations
  • Data Review and Reporting
  • Data Retention and Retrieval
  • Addressing Data Reliability Issues


Lesson 9: Implementation of cGxP


  • GxP Readiness Checklist
  • Prepare for Your Validation Process








Dr. Faheem S. Khawaja
Dr. Faheem S. Khawaja (PharmD, MS) works as a Research Manager at Prime Foundation, with 5 years of professional experience in healthcare and academia with a research interest in pharmaceutical nanotechnology and drug delivery systems. He is a highly capable and motivated Healthcare professional with superior analytical and problem-solving skills. Faheem possesses extensive knowledge of Pharmaceuticals and their regulatory bodies, database design, and medical informatics.


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This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

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$60.00 / year

$60.00 / year

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