In this course the learner will be introduced to 21 CFR Part 820.100  Subpart J – CAPA.  21 CFR 820.100 is an important element of the medical device quality system regulations. CAPA is continually one of the top 483 observation made by the FDA each year. This CAPA training will help you to understand the CAPA requirements in 21 CFR 820 Subpart J.

Participants will learn about how CAPA can be audited using the Quality Inspection Technique. They will also learn about the FY2021 form 483 CAPA observations.

Who should take this course?

Personnel involved in any part of a CAPA system; these may include Quality Engineers, Line Operators, Production Staff, Internal Auditors, Subject Matter Experts and Technical Staff.

1. Learn about the content of 21 CFR 820.100 – CAPA.

2. Gain understanding of the definitions of the terms relating to CAPA.

3. Gain an understanding of the importance of determining the true root cause of a problem.

4. Gain knowledge about the importance of documenting all steps undertaken in a CAPA project.

5.  Gain knowledge about how CAPA is an area that is frequently scrutinized during FDA inspections.

6. Obtain knowledge about the Quality Inspection Technique of Auditing CAPA.

7. Gain knowledge about the CAPA FY2021 CAPA observations.

6. Learn about a Warning Letter documenting issues relating to 21 CFR 820 .100 – CAPA.

The following topics will be covered in this course;

• CAPA definitions (CAPA, Correction, Corrective action and preventative action),
• 21 CFR Part 820 Subpart J requirements,
• The CAPA process,
• Quality Inspection Technique and CAPA.
• FY2021 FDA Form 483 CAPA observations.
• FDA CAPA related warning letters.

Supplemental Material:

(a) The link to 820.100 (CAPA) of 21 CFR 280 The Quality System Regulation.

(b) The FDA’s Quality System Inspection Technique Manual.

(c) You will get access to a downloadable infographic that will highlight the key elements of a CAPA process.

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. 

You will be allowed 3 attempts to pass the quiz. 

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.