In this course, 21 CFR 820 Subpart E Medical Device Purchasing Controls Online Training Course, the learner will be introduced to the section of 21 CFR 280 that covers purchasing controls. 21 CFR 820 is also known as the medical device The Quality System Regulation (QSR). The learner will also learn about form 483s and warning letters that cite 21 CFR 820 Subpart E noncompliance.

One of the most frequent clause citations in FDA form 483s and warning letters is purchasing controls. Purchasing controls is where a quality system establishes the process for choosing and controlling suppliers.

Since the medical device industry heavily relies on contracted goods that are ultimately integrated with the finished goods, this clause carries much weight. 

Whether you have an audit coming or you’re implementing the QSR, you need to pay special attention to Purchasing Controls. 

Who should take this course?

• Any personnel, suppliers or contractors involved in purchasing activities.
• Supplier quality engineers
• Any suppliers to medical device companies.
• Internal auditors.

1. Learn about the content of 21 CFR 820 Subpart E – Purchasing Controls.

2. Gain knowledge about FY2021 Form 483 observations about purchasing controls.

3. Gain knowledge about a warning letter documenting issues relating to 21 CFR 820 Subpart E – Purchasing Controls.

The following topics will be covered in this course:

• Purchasing Control related definitions (“Component”, “product”, “service” and “establish”).
• Who Purchasing Controls are applicable to.
• 21 CFR Part 820 Subpart E requirements.
• Example of a supplier auditing checklist.
• FY 2021 Form 483 observations relating to purchasing controls.
• Review FDA warning letters that cited the purchasing control clause. 

Supplemental Material:

1. Link to 21 CFR Part 820 Subpart E – Purchasing Controls.
2. Sample supplier evaluation procedure.

Assessment:

Quiz, consisting of 11 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.