1 - 2 hours. Learning times vary dependent on the learner’s preferred pace.
Beginner (no knowledge at all of the topic)
6 months, 24/7 access
A certificate of completion will be issued on successful course completion.
In this training course you will learn about 21 CFR Part Subpart J. 21 CFR 211 Subpart J is an important element of the cGMP programme. It is contained in 21 Code of Federal Regulations Part 211: the cGMP in Manufacturing, Processing, Packaging, or Holding of Drugs.
Who should take this course?
1.Gain knowledge about 21 Code of Federal Regulations Part 211: the cGMP in Manufacturing, Processing, Packaging, or Holding of Drugs.
2. Learn about the content and structure of 21 CFR Part Subpart J Records and Reports.
The following topics will be covered in this course:
Link to 21 CFR Part 211 Subpart J – Records and Reports
There will be an end of course quiz. The Quiz will consist of 10 questions.
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.