Length of Course
7- 8 hours. Learning 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 certificate of completion will be issued on successful course completion.
This FDA cGMP Requirements for Drug/Device Combination Products Online Training Course gives manufacturers important regulatory knowledge. It gives participants an in dept look at the FDA cGMP requirements for drug/device combination products. It covers the different options that are available when implementing cGMP requirements for drug/device combination products.
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.
Because of this, combination products do not fit into a single regulatory framework and they are thus more complex than average products in terms of determining the optimum regulatory pathways involved with getting them to market.
Who should take this course?
- Those who work in a drug/device combination product cGMP environment (from beginner to advanced professionals).
- All employees, contractors, consultants, and suppliers currently supporting or wanting to support drug/device combination product FDA cGMP regulated activities.
- Those whose roles and responsibilities require they understand and apply drug/device combination product cGMP quality principles to their job.
- Professionals who wish to work in the drug/device combination product manufacturing sector.
Upon completion of this course participants should be able to:
1. Demonstrate a basic knowledge of a CGMP requirements for drug/device combination products.
2. Understand the similarities and differences in drug and device CGMP regulations.
3. Interpret the CGMP requirements for combination product for their day-to-day operations.
4. Learn about recent Warning Letters findings related to specific parts of the CGMPs .
Section 1: Introduction
Lesson 1 – Course Structure
– How to get the most out of this Course
Section 2: Combination Products cGMP Regulations
Lesson 2 – Drug/Device Combination Products CGMP Requirements
Lesson 3 – FDA Current 21 CFR Part 4 GMP requirements for Combination Products.
Lesson 4 – Walk-through cGMP Final Guidance for Part 4 (combination products)
Section 3 – Option 1: Implement Drug cGMP (21 CFR 210/211) and the Device Quality System Regulation
Lesson 6 – 21 cfr 820 – FDA Medical Device Quality System Regulation
Lesson 6 – 21 CFR Part 210 Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs
Lesson 7 – 21 CFR 211, cGMP for finished pharmaceuticals
Section 4 – Option 2: Implement Drug cGMP and the following provisions from the Device QS regulation
Lesson 8 – 820.20 Management Responsibility
Lesson 9 – 820.30 Design Controls
Lesson 10 – 820.50 Purchasing Controls
Lesson 11 – 820.100 Corrective and Preventative Action
Lesson 12 – 820.170 Installation
Lesson 13– 820.200 Servicing
Section 5 – Option 3: Implement Device QS regulation and the following provisions from the Drug CGMP
Lesson 14 – 21 CFR 211.84 – Testing and approval or rejection of components, drug product containers, and closures
Lesson 15 – 21 CFR 211.103 Calculation of Yield
lesson 16 – 21 CFR 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.
Lesson 17 – 21 CFR 211.137 Expiration Dating/211.166 Stability Testing
Lesson 18 – 21 CFR 211. 165 Testing and Release for Distribution
Lesson 19 – 21 CFR 211.167 Special Testing Requirements
Lesson 20 – 21 CFR 211.170 Reserve Samples
Section 6 – Sample Warning Letters
Lesson 21 – Warning letters relating to cGMP Drug/Device Combinations products
There be links the relevant parts of the combination products regulations shared throughout the course.
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.