cGMP, Quality by Design (QbD), aseptic processing, biologics
– Are you an engineer or a scientist who wants to break into the emerging biomanufacturing field?
What you’ll learn
- Comprehensive Understanding and Practical Application of cGMP Principles.
- Quality by Design and Process validation.
- Levels of Quality Management Systems.
- Control strategies.
- Cleanroom requirements.
Course Content
- Introduction –> 2 lectures • 6min.
- Module 1: Background –> 1 lecture • 3min.
- Module 2: Quality Management System (QMS) –> 2 lectures • 6min.
- Module 3: GxP in Biopharmaceutical Industry –> 10 lectures • 20min.
Requirements
– Are you an engineer or a scientist who wants to break into the emerging biomanufacturing field?
– Are you an R&D specialist who wants to know more about the bioprocess development and validation?
– Are you working in Market Access or Regulatory Affairs that need to know the language used in cGMP?
If you’ve answered yes to any of these questions, this course is designed for you! I’m Taylor, with an MEng degree in Biomanufacturing from a World Top 30 university and years of experience in the biopharmaceutical industry, I’ve launched BioMANU, a channel aimed at disseminating essential knowledge about biomanufacturing. I truly believe that by having more professionals access to cutting-edge processes, we can enhance global biologics supply while reducing costs.
Biologics are shaping the future of pharmaceuticals, making it crucial for professionals to grasp essential cGMP components. Throughout this 30-minute crash course, you will gain insight into vital concepts of cGMP in biomanufacturing. This includes its distinctions from traditional pharmaceutical practices, the quality by design (QbD) framework, environmental monitoring, aseptic processing, process validation, and more. By mastering cGMP principles, it will not only elevate your work standards but also foster seamless communication and collaboration across diverse teams within the industry.
Feel free to explore our demo videos and other courses related to biomanufacturing that we offer. I can’t wait to have you join us!