Length of Course
2 - 3 hours. Learning times vary dependent on the learner’s preferred pace.
Level of Difficulty
Beginner (no knowledge at all of the topic)
Access to Content
6 months, 24/7 access
Certificate of Completion
A certificate of completion will be issued on successful course completion.
In this course, 21 CFR Part 210 – cGMP in Manufacturing, Processing, Packing, or Holding of Drugs Online Training Course, you will learn about Title 21 of the US Code of Federal Regulations, Part 210 (21 CFR 210). The FDA current good manufacturing practices (cGMP) regulations for drugs are published in this title in addition to 21 CFR 211.
cGMPs is a system for ensuring products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. In this 21 CFR Part 210 training course you will learn the fundamentals of the drug cGMPs.
Who should take this course?
- Those who work in a current Good Manufacturing Practices (cGMP) environment (from beginner to advanced professionals) and those whose roles and responsibilities require they understand and apply cGMP quality principles to their job.
- All employees, contractors, consultants, and suppliers currently supporting or wanting to support FDA cGMP regulated activities.
- Professionals who wish to work in the pharmaceutical manufacturing setting.
- Understand drug cGMPs.
- Gain knowledge about where the cGMP regulations came from.
- Understand what the Food Drug and Cosmetics Act 1938 is.
- Have knowledge of the content and structure of 21 CFR 210.
- Gain knowledge of terms used in 21 CFR 210.
- Gain knowledge about what types of cGMP violations appear in FDA warning letters.
Topics covered in this course
- Review of each section of 21 CFR 210.
- Review of definitions contained within 21 CFR 210.
- Review of warning letters that document to cGMP violations.
End of course quiz.
Upon completing the course and when you obtain a passing grade on your final quiz (80% or over), you will receive a PDF certificate to show that you have completed all the course content.
Dr. Fiona Masterson
Fiona is the founder of The Learning Reservoir. She has 25+ years of parallel paths in quality management, operations management and education. She has broad technical expertise encompassing quality systems compliance, quality standards implementation, regulatory affairs and operations management. She has worked in start-ups and high‐tech, fast paced manufacturing environments. She lectures part-time in technical universities on subjects related to her industrial expertise.
Fiona has Bachelor and Masters of Science degrees, and a Doctorate in Mechanical Engineering. Her Doctorate focused on innovative drug/device combinations products. Fiona is a certified lead auditor. Fiona has published in peer reviewed journals on topics such as medical device and pharmaceutical regulatory affairs, on-the job training and innovative training technologies and strategies.
She writes many of The Learning Reservoir’s blog posts and invites you to connect with her on LinkedIn.