Length of Course
1 hour. 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 certificates of completion will be issued on successful course completion.
in this course you will learn about 21 CFR 211 Subpart D – Equipment. 21 CFR 211 Subpart D is contained within 21 Code of Federal Regulations Part 211: the cGMP in Manufacturing, Processing, Packaging, or Holding of Drugs (21 CFR 211). It is important that equipment used in the manufacture of pharmaceuticals does not become a source of contamination.
Who should take this course?
- Any new or existing manufacturing and quality department personnel, suppliers or contractors involved in operations pertaining to medicinal products.
- Anyone needing to understand equipment cGMP regulations for pharmaceutical products.
1.Gain an understand where Subpart D fits into 21 Code of Federal Regulations Part 211: the cGMP in Manufacturing, Processing, Packaging, or Holding of Drugs.
2. Learn about the different sections of 21 CFR Part 211 Subpart D – Equipment
The following topics will be covered in this course:
- Overview of 21 CFR 211.
- 21 CFR Part 820 Subpart D requirements.
- The practical aspects of complying with Subpart D.
Link to 21 CFR Part 211 Subpart D – Equipment.
There will be a quiz at the end of this course. 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 has 20+ years of parallel paths in quality management, operations management and education. She is a highly experienced quality and training professional, with broad technical expertise encompassing quality systems compliance, quality standards implementation, regulatory affairs and operations management. she is experienced with start-ups and high‐tech, fast paced manufacturing environments.
Fiona has a Bachelor of Science degree in Food Science, a Master of Science degree in Quality and Operations Management, and a Doctorate in Mechanical Engineering. Her Doctorate focused on innovative drug/device combinations products. Fiona is also a certified lead auditor.Fiona has published in peer reviewed journals on topics such as regulatory affairs and innovative training methodologies
She writes many The Learning Reservoir’s blog posts and invites you to connect with her on LinkedIn.