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FDA QSR (21 CFR Part 820) Fundamentals
"FDA QSR (21 CFR Part 820) Fundamentals" provides essential knowledge of regulatory requirements governing quality systems in medical device manufacturing. This course ensures compliance with the FDA’s quality system regulations, focusing on documentation, CAPA processes, and design controls. From a cybersecurity perspective, participants gain insights into the integration of digital quality systems and secure data management practices. Understanding how to mitigate cyber risks in regulated environments is crucial, particularly as connected medical devices and electronic records increase exposure to cyber threats. The course empowers professionals to ensure both regulatory compliance and robust cybersecurity hygiene.
Course Overview
Overall Proficiency Level
2 - Intermediate
Course Catalog Number
T101
Course Prerequisites
None
Training Purpose
Functional Development
Management Development
Specific Audience
All
Delivery Method
Online, Instructor-Led
Learning Objectives
- Understand the requirements of FDA QSR (21 CFR Part 820).
- Apply QSR principles to medical device manufacturing processes.
- Develop and implement quality management systems compliant with 21 CFR Part 820.
- Analyze and interpret FDA regulations related to medical device quality.
- Prepare for FDA inspections and audits related to QSR compliance.
Framework Connections
The materials within this course focus on the NICE Framework Task, Knowledge, and Skill statements identified within the indicated NICE Framework component(s):
Competency Areas
Feedback
If you would like to provide feedback on this course, please e-mail the NICCS team at NICCS@mail.cisa.dhs.gov. Please keep in mind that NICCS does not own this course or accept payment for course entry. If you have questions related to the details of this course, such as cost, prerequisites, how to register, etc., please contact the course training provider directly. You can find course training provider contact information by following the link that says “Visit course page for more information...” on this page.
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