This drug/device combination products cGMP reserve samples (21 CFR 211.170) online training course online training course gives the learner an understanding of the FDA requirements for reserve samples (21 CFR 211.170) for drug/device combination products. Reserve samples are important to verify original test results in case there is some doubt about previous test results. Reserve samples are also important for studies to get additional information and are required by various regulatory bodies.

Drug/device combination products combine two or more single-entity products. They include drugs combined with medical devices, drugs combined with biologics, and medical devices combined with both a drug and a biologic. Drug/device combination products are unusual from a regulatory point of view, as they include products that originate in the pharmaceutical, biopharmaceutical, biotechnology, and medical device sectors, which differ conventionally 

.

Who should take this course?

• Those who wish to get an introduction to the FDA cGMP requirements for reserve samples for drug/device combination products. 

1. Gain knowledge about the structure and contents of 211.170.

2. Gain knowledge of terms used in 211.170.

3. Obtain understanding about a Warning Letter documenting issues relating to 211.170.

The following topics will be covered in this course;

• FDA Current 21 CFR Part 4 GMP requirements for Combination Products.
• Walk-through cGMP Final Guidance for Part 4 (combination products).
• Requirements for reserve samples (21 cFR 211.170) for drug/device combination products.
• Understand the meaning of “Active ingredient”, ” lot” and “Representative Sample”.
• Review of warning letter related to 21 CFR 211.170 non-compliances. 

Supplemental Material:

Links to the relevant regulations/guidance documents will be supplied. 

Assessment:

There will be a quiz at the end of the course.

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.