Regulation

Everyone
  • 7 videos | 42m 13s
Likes 1 Likes 1
Learn about biomanufacturing regulation.

WHAT YOU WILL LEARN

  • Understand the basics of regulation
    Understand process control, validation and product testing
    Understand quality by design
    Understand manufacturing process variants
  • Understand more about manufacturing process variants
    Understand the industry from an expert perspective
    Understand the industry from an expert perspective

IN THIS COURSE

  • Playable
    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
  • Playable
    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
  • Locked
    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
  • Locked
    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
  • Locked
    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
  • Locked
    6.  Meet The Experts: Charles L. Cooney
    6m 21s
    Learn more about the industry from an expert perspective FREE ACCESS
  • Locked
    7.  Meet The Experts: Janet Woodcock
    5m 27s
    Learn more about the industry from an expert perspective FREE ACCESS

YOU MIGHT ALSO LIKE