Statistics 101 and Statistical Quality Control for Biopharmaceuticals (virtual)


  • July 31 - August 4, 2023

Location (in-person)

  • UMass Lowell, Lowell, Massachusetts

Course Description

  • This course teaches the basic statistical principles, state-of-the-art concepts, advanced tools, and available techniques for statistical process monitoring, quality fault detection, and continues improvements for wide variety of applications including biomedical and pharmaceutical manufacturing applications.


  • Wenzhen Huang (UMass Dartmouth), Bharatendra K Rai (UMass Dartmouth), Seongkyu Yoon (UMass Lowell). 

Target Audience

  • Manufacturing Process Engineer, Quality Engineer, Research Scientist, Bioprocess Engineer


At the completion of this course the participant will be able to:

  • Discuss and describe quality management philosophies
  • Discuss quality improvements with six sigma strategy and DMAIC
  • Describe, compute, summarize, and interpret sample statistics of manufacturing process data
  • Explain concepts of sampling, sampling distribution, parameter estimation of population
  • Design, set up, and use CUSUM and EWMA charts
  • Understand some recent developments of SPC control chart for specific applications: short run, autocorrelated process and multivariate processes


  • M1. Intro to 6s, Deming 14 points, and statistical quality control
  • M2. Introduction to Statistical Basis of Statistical Quality Control
  • M3. Statistical Inference: Hypothesis testing and T1/T2 errors
  • M4. Control Charts for SPC, Process Monitoring and Fault Detection
  • M5. Enhancements of SPC Charts: CUSUM & EWMA charts
  • M6. Quality Characterization, Process Capabilities, Gauge R&R
  • M7. Multivariate Statistics (PCA)
  • M8. Multivariate Control Charts (MSPC): Multivariate Process Monitoring


The cost of attendance is $2,500; there is a 50% discount for academic and government. The deadline to register is July 15, 2023.

Statistics 101 and Statistical Quality Control for Biopharmaceuticals Online Registration

Contact Information

  • © 2020 The National Institute for Innovation in Manufacturing Biopharmaceuticals. All rights reserved. This project was developed with an award from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance from the U.S. Department of Commerce, National Institute of Standards and Technology (70NANB17H002).