Learn the Current Good Manufacturing Practices requirements for laboratory controls for drug products.
Length of Course
4 - 5 hours. Times vary dependent on the learner’s preferred pace.
Level of Difficulty
Basic (a very basic knowledge of the topic but no professional usage)
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 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?
- Any new or existing manufacturing and quality department personnel, suppliers or contractors involved in working in or interacting with the quality control laboratory.
- Anyone needing to understand the cGMP laboratory controls that are required in the pharmaceutical industry.
- Individuals in the following positions or seeking these positions: Quality Control technician, Quality Control Analyst, QA Chemist, R& D Chemist, Microbiologist and Internal Auditors.
- Gain an understand about how Subpart I fits into 21 CFR 211.
- Learn about the the requirements within 21 CFR Part 211 Subpart I Laboratory Controls.
- Learn about the requirements within of § 211.160 – General requirements.
- Learn about the requirements within of § 211.165 – Testing and release for distribution.
- Learn about the requirements within of § 211.166 – Stability testing.
- Gain an understanding how § 211.137 Expiration Dating relates to § 211.166 Stability Testing.
- Learn about the requirements within of § 211.167 – Special testing requirements.
- Learn about the requirements within of § 211.170 – Reserve samples.
- Learn about the requirements within of § 211.173 – Laboratory animals.
- Learn about the requirements within of § 211.176 – Penicillin contamination.
- Learn about Warning Letters citing noncompliances to 21 CFR Part I – Laboratory Controls.
The following topics will be covered in this course:
- Tips on how to be successful at taking the course.
- Overview of 21 CFR 211
- Subpart I – Laboratory Controls
- § 211.160 – General requirements
- § 211.165 – Testing and release for distribution
- § 211.166 – Stability testing
- How § 211.137 Expiration Dating relates to § 211.166 Stability Testing
- § 211.167 – Special testing requirements
- § 211.170 – Reserve samples
- § 211.173 – Laboratory animals
- Warning letters that contain 21 CFR 211 Subpart I cGMP non compliances.
The following regulations/documents will be shared with participants throughout the course:
- 21 CFR 211
- Subpart I of 21 CFR 211
- The Guide to Inspection of Pharmaceutical Quality Control Laboratories
- FDA Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories
- The FDA Questions and Answers on Current Good Manufacturing Practices—Laboratory Controls
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.