This 21 CFR Part 4 (Subpart A) – cGMP for Combination Products Online Training Course will discuss the FDA final guidance covering good manufacturing practice (cGMP) requirements for combination products. The final guidance covers the purpose and content of the cGMP requirements included in the final ruling.

The final rule is known as 21 Code of Federal Regulations (CFR) part 4. Before issuance of the final rule, there were no regulations to clarify and explain the application of these cGMP requirements to combination products. The final rule did not establish any new requirements. It was intended to clarify which cGMP requirements apply when drugs, devices, and biological products are combined to create combination products, and to set forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with applicable cGMP requirements.

Who take this course?

• Individuals who are involved with manufacturing combination products.
• Individuals who want to understand what are cGMP for combination products. 

1. Gain an understanding of the definition for a drug/device combination product.

2. Know the structure of 21 CFR Part 4.

2. Gain an understanding about the contents of 21 CFR Part 4.

The following topics will be covered in this course:

• Title 21 of the Code of Federal Regulations Part 3.2(e), Product Jurisdiction
• Single-entity combination products.
• Drug eluting stents.
• Transdermal patches.
• Surgical kits.
• Products co-packaged in a kit.
• Separate cross-labelled products.
• The structure of 21 CFR Part 4
• The content of 21 CFR Part 4.

Supplemental Material:

A link to the regulations that contain the definition of a combination product and 21 CFR Part will be shared with you. 

Assessment:

Quiz consisting of 10 multiple choice 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.