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Home » Medical Device: US Quality System Requirements (21 CFR PART 820)

Medical Device: US Quality System Requirements (21 CFR PART 820) (MDU2)

Certification Training
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Method of Training: Online / Self-paced eLearning.
Credit Hours: 2 credits.
Duration: ~2 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

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Biopharma Institute LogoTraining Program: Medical Device: US Quality System Requirements (21 CFR PART 820)
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

Implementing a quality system for medical devices can be a complex process. This model will help the student to assimilate all of the required knowledge necessary to implement a quality system in accordance with the 21 CFR 820 regulations. Course objectives are: To identify what documentation is required for quality system, to explain the role of key stakeholders in maintaining and establishing a quality system, to identify the requirements of the quality system, and to state how 21 CFR PART 820 relates to the medical device industry.

The course includes an introduction and topics such as production assurance, responsibilities and roles, quality systems, FDA inspection, product documentation, quality assurance, and a conclusion that summarizes the previously listed topics.

Once all course requirements have been satisfied, students will immediately receive a certificate of completion (PDF) and have been introduced to appropriate guidelines and pharmaceutical industry standards. This program assures that the student will understand the federal regulation compliances and how to conduct work which adheres to these standards.

This online training program includes immediate access after enrollment. Username, password, and instructions are emailed to the student following the enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade. Once all course requirements have been satisfied, a certification of training has been achieved and a certificate is immediately made available to the student.

Benefits of Getting Certified at Biopharma Institute

Throughout many of our courses, students will engage in active learning using interactive eLearning modules developed to promote the learning of key knowledge and information. For companies seeking a method to train employees, economically, without having to set aside an entire day for them to attend a live course, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, interactive, self-paced learning experience which fits in with most types of learners. We cater to both small-scale and large-scale training requests, customizing your employee's education.

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


1. Welcome
2. Introduction
3. Reviews and Assessments

4. Overview of 21 CFR 820
5. Quality System Definition
6. More on Quality Systems
7. QSRs
8. Implementation
9. Quality System Linkages

10. Overview
11. Management
12. Management Representative
13. Company Personnel
14. Review

15. Overview
16. Product Assurance
17. Design Control Overview
18. Design Control
19. Purchasing Control
20. Identification/Traceability
21. Process Control
22. Control of Production Processes
23. Process Validation
24. Device Labeling
25. Handling

26. Overview
27. Acceptance Activities
28. Nonconforming Products
29. CAPA
30. Servicing and Repair
31. Statistical Techniques
32. Review

33. Overview
34. Device Master Record
35. Device History Record
36. Complaint Files
37. Review

38. Introduction
39. Inspection Procedure
40. FDA Inspection Guidance

41. Summary


State how 21 CFR 820 relates to the medical device industry.
Identify the requirements of the quality system.
Explain the role of key stakeholders in establishing and maintaining a quality system.
Identify what documentation is required for quality system.

The Medical Device: US Quality System Requirements (21 CFR PART 820) Course is Included in the Following Professional Certification Programs:

US Medical Device Regulatory Affairs Professional Certification Program: This online certification program provides an introduction to the Code of Federal Regulations (CFRs). It introduces students to the activities that are essential prior to a device being set to go to the United ... Learn more

Medical Device Quality Management System (QMS) Professional Certification Program: This certification program supplies an excellent introduction to the key points in maintaining a quality management system (QMS). Course objectives include training how to recognize the importance of measuring ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter.
  • Self-paced courses: 24/7 access to individual courses for 90 days, and for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

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