In this Introduction to 21 CFR 820 (Medical Device Quality System Regulation) Online Training Course  participants learn about this quality system regulation for medical devices. The FDA’s 21 CFR Part 820 is also known as the Quality System Regulation (QSR). It also teaches learners about the Quality System Inspection Technique (QSIT).  Form 483s observations for FY 2021 will also be reviewed.

21 CFR 820 outlines the Current Good Manufacturing Practice (cGMP) regulations that govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. These requirements are meant to ensure that medical devices are safe and effective. Medical device manufacturers undergo FDA inspections to ensure FDA 21 CFR 820 compliance.

QSIT provides guidance to the FDA field staff on the inspectional process that may be used to assess a medical device manufacturer’s compliance with the QSR.  Field investigators generally will use this guidance material to help them focus on key elements of a firm’s quality system. 

In this 21 CFR 820 Quality System Regulation training course the FDA form 483 observations for FY2021 will be also reviewed. This provides an unique insight for the learner to what areas medical device manufactures are struggling with when complying with 21 CFR 820.

Who should take this course?

This CFR 820 Quality System Regulation training course is designed for ALL functions and levels of an organization in the medical device sector who need to gain some understanding of the US FDA 21 CFR Part 820 requirements and how it can be inspected by the FDA. 

1. Understand the scope of 21 CFR Part 820 (The Quality System Regulation).  
2. Learn about the content of 21 CFR Part 820.
3. Obtain knowledge about the Quality System Inspection Technique (QSIT).
4. Gain an insight into form 483s 21 CFR 820 observations that were made in FY2021.   

The following topics will be covered in this course:

• Each clause of 21 CFR 820 will be addressed.

             A – General provisions
             B – Quality system requirements
             C – Design controls
             D – Document controls
             E – Purchasing controls
             F – Identification and traceability
             G – Production and process controls
             H – Acceptance activities
             I – Non-conforming product
             J – Corrective and preventative action
             K – Labelling and packaging control
             L – Handling, storage, distribution and installation
             M – Records
             N – Servicing
             O – Statistical techniques

• Quality System Inspection Technique.
• QSIT approach to auditing Corrective & Preventive action
• QSIT approach to auditing Management Controls
• QSIT approach to auditing Production and Process Controls
• QSIT approach to auditing Design Controls
• There will be a review of form 483 21 CFR 820 observations for FY2021.

Assessment:

There will be an end of course quiz consisting of 20 questions.

Supplemental Material:

There will be a links shared with you to:

21 CFR 820.

Quality System Inspection Technique.

Form 483 observations for FY2021.

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.