In this course you will learn about 21 CFR Part 211 Subpart E Control of Components and Drug Product Containers and Closures. 21 CFR Part 211 Subpart E is can be found in 21 Code of Federal Regulations Part 211: cGMP in Manufacturing, Processing, Packaging, or Holding of Drugs (21 CFR 211).
FDA ensures the quality of drug products by carefully monitoring drug manufacturers’ compliance with its cGMP regulations. The cGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product. The regulations make sure that a product is safe for use, and that it has the ingredients and strength it claims to have
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 cGMP regulations for medicinal products.
The following topics will be covered in this course:
- Overview of 21 CFR 211.
- 21 CFR Part 820 Subpart E requirements.
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.