Statistical Process Control


Duration :



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 ourย certificate online checker. They can also be shared on Linkedin.


In addition to the efficacy and safety of pharmaceutical products and devices, a major goal of the manufacturing process is the uniformity of products. Hence pharmaceutical companies use statistical process controls (SPC) to contain the stability, variability, and capability of the manufacturing process. This course introduces you to the basics of calibrating processes and determining standards for evaluation of the reproducibility of the products of your manufacturing process. It includes lessons on control charts, measures of central tendencies, measures of variability, and other statistical tools.


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.






  • What Is a Process?
  • Why Is There a Need to Have a Statistical Process Control?
  • Emphasis on the Need for Process Understanding and Control
  • Are There Any Guidelines Available for The Statistical Process Control?
  • The Goal of Statistical Process Control
  • What Is a Variation?
  • What Are the Sources of Variations?
  • What Are Control Charts?


Lesson 1: Statistical Basis of the Control Chart


  • The Mean
  • The Range and Standard Deviation
  • Distribution of Data
  • What is the Median


Lesson 2: Control Charts


  • Basic Principles
  • How to Plot Control Charts
  • Types of Control Charts


Lesson 3: The x-Bar Charts


  • Estimating Central Tendency of the Process
  • What If Some Observations Do Not Appear Within Control Limits?
  • X-Bar Charts Estimating Variability of the Process


Lesson 4: The Range (R) Charts


Lesson 5: The p-Charts


Lesson 6: The c-Charts








Dr. Khurram Rehman
Dr. Khurram Rehman is a Pharmacist and an Academician. He received his Master in Pharmaceutical Analysis and Doctor of Philosophy in Pharmacy from the National University of Malaysia (Universiti Kebangsaan Malaysia). He has several years of professional experience working in the Pharmaceutical Industry and Research and Development organizations. Currently, he is actively involved in academia and research and has many publications to his name. In addition, he has a keen interest in Pharmaceutical Analysis, Quality Management, and Drug Delivery Sciences. He firmly believes that bringing academia and industry together can only ensure continuous professional development, up-to-date knowledge, and the best productivity.


USD: United States (US) dollar ($) ^


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

GxP-Training Benefits

[finale_countdown_timer campaign_id="40465" skip_rules= "yes"]



We might have this course but it's not displayed online. Please type your email and we will get back to you within 24h

No video yet for this course