This online training course will present an in-depth look at 21 CFR Part Subpart C Design Controls. Subpart C is an important element of the medical device Quality System Regulation (QSR). The learner will be given an insight into the form 483 design controls observations for FY2021.

Design controls are essential to ensuring a medical device idea achieves regulatory approval. Without design controls, you won’t be able to launch your product, while the poor implementation of design controls, particularly in the early stages of a project, will delay the launch of your product. Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.

Who should take this course?

• This online course is suitable for professionals involved in the development of medical devices or planning to work in this area.
• Individuals in the following positions or seeking these positions in the medical device industry: new product development/R&D engineers, project managers, regulatory affairs specialists. It is also suitable for Internal auditors. 

1. Learn about the content of Subpart C – Design Controls.

2. Learn about the relevance of Subpart C to 820.30 of the FDA’s Design Control Guidance For Medical Device Manufacturers.

3. Gain insight how design controls can be audited using the Quality System Inspection Technique manual.

4. Obtain knowledge about the design controls form 483 observations in FY2021. 

5. Learn about a Warning Letter documenting issues relating to Subpart C – Design Controls.

The following topics will be covered in this course:

• Each requirement within 21 CFR Part 820 Subpart C will be discussed.
• Design development plan
• User needs
• Design inputs
• Design outputs
• Design review
• Design verification
• Design validation
• Design transfer
• Design changes
• Design History File
• The FDA’s Design Control Guidance For Medical Device Manufacturers and Quality System Inspection Technique manual.
• FY2021 FDA form 483 observations for FY2021.
• Warning Letter documenting issues relating to Subpart C – Design Controls.

Supplemental Material:

1. Link to 21 CFR Part 820 Subpart C – Design Controls
2. Quality System Inspection Technique.

Assessment: 

Quiz consisting 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.