21 CFR Part 211 Subpart I (Laboratory Controls for Finished Pharmaceuticals) Online Training Course
€425.00
€425.00
Learn the Current Good Manufacturing Practices requirements for laboratory controls for drug products.
Self-paced elearning
Quiz
4 - 5 hours. Times vary dependent on the learner’s preferred pace.
Closed Captions
Basic (a very basic knowledge of the topic but no professional usage)
6 months, 24/7 access
A certificates of completion will be issued on successful course completion.
In this course you will learn about 21 CFR Part 211 Subpart I Laboratory Controls. 21 CFR 211 Subpart I is an important part of 21 Code of Federal Regulations Part 211: the cGMP in Manufacturing, Processing, Packaging, or Holding of Drugs (21 CFR 211).
The pharmaceutical quality control laboratory is one of the most vital functions in pharmaceutical production and control. A substantial portion of the CGMP regulations (21 CFR 211) pertain to the quality control laboratory and product testing. During FDA inspections it is one of the most one of the most scrutinized areas. The laboratory is involved in the critical tasks of the release of raw materials, performing in-process, release, and stability tests.
Who should take this course?
The following topics will be covered in this course:
Supplemental Materials
The following regulations/documents will be shared with participants throughout the course:
Assessment
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.