21 CFR Part 820 (Medical Device QSR) – Practice Exam

21 CFR Part 820 – Quality System Regulation is the set of regulatory requirements on Quality System for medical devices manufacturers in the U.S.A. The regulation is not only applied in the U.S. but also many other countries have taken inspiration from it for making their own regulations or adopting it as a guidance. It is one of the important regulatory document on medical device manufacturer’s Quality System. If you are a quality or regulatory professional or beginner in the medical devices industry, you should check your expertise in Quality System Regulation (QSR). This “knowledge validation exam” helps you to check and validate your knowledge on 21 CFR Part 820 regulation and its fundamental concepts.

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Value Addition Alerts:

1. Passing Certification Awarded By Instructor

2. Road Map for Further Learning

Certification:Udemy does not provide certification for exams, they only do in the case of Video Courses. But the great news here is, we have empowered our paid students to have a certificate, once they qualify by 80% in the exams. It is a manual process, in which learners our requested to submit evidence of qualification, and apply for the certificate. The certificates are issued at the end of a month.

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Exam Composition

The exam is based on all sub parts of the regulation. Therefore You will be assessed when you take this online exam in following areas (Course Objectives):

• General Provisions

• Quality System Requirements

• Design Controls

• Document Controls

• Purchasing Controls

• Identification and Traceability

• Production and Process Controls

• Acceptance Activities

• Nonconforming Product

• Corrective and Preventive Action

• Labeling and Packaging Control

• Handling, Storage, Distribution, and Installation

• Records

• Servicing

• Statistical Techniques

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Food for Thought

Be Familiar with 21 CFR Part 820 knowledge which you hold…

If you think you are an expert in 21 CFR Part 820 after taking courses on the subject and working with QSR…

You need to hold on!

Join this exam and self assess yourself!

Maybe you need to learn and learn…

Or you can prove your knowledge and expertise by successfully completing this exam.

Both ways, you are in a win-win situation.

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Good news: We will be adding more content for example case studies to practice tests in the future. If you feel that you lack the knowledge you can take 21 CFR Part 820 courses from Udemy or the instructor to guide you on gaining 21 CFR Part 820 knowledge.

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Ask Questions & Report Complaints:Discussion forum on the right side of this course can be used to discuss specific queries and report problems you are facing about the content of the course.

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