Regulation

IN THIS COURSE

• 1.  Introduction To Regulation
  7m 32s
  In the following lecture, Dr. Stacy Springs looks at the beginnings of regulation in the United States in more detail. FREE ACCESS
• 2.  Process Control, Process Validation, & Product Test
  5m 52s
  In the lecture that follows, Dr. Stacy Springs will introduce you to the concepts of process control, process validation, and product testing, as well as tell you about the three stages to process validation.  FREE ACCESS
• 3.  Quality By Design
  4m 57s
  In this video segment, Dr. Stacy Springs describes in more detail each element of QbD and its importance in biomanufacturing. FREE ACCESS
• 4.  Manufacturing Process Variants Part 1
  6m 11s
  In the following lecture, Dr. Springs walks you through several examples to explain the difference between product-related impurities and product-related substances. FREE ACCESS
• 5.  Manufacturing Process Variants Part 2
  5m 56s
  In this final segment on regulatory processes, Dr. Springs examines how manufacturing process changes can cause changes to the end product and how this can impact a manufacturer's ability to license the product. FREE ACCESS
• 6.  Meet The Experts: Charles L. Cooney
  6m 21s
  Learn more about the industry from an expert perspective FREE ACCESS
• 7.  Meet The Experts: Janet Woodcock
  5m 27s
  Learn more about the industry from an expert perspective FREE ACCESS