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Tuesday, June 27, 2017
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Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820 (MDU2)

Certification Training Duration: 1.7 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Demonstration: Demo an online course.

Certificate: View sample certificate.

PRICE: USD $169.00

dinaris.org LogoTraining Program: Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

Implementing a quality system for medical devices can be a complex process. This model will help you 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 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, a certificate of completion is immediately available. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade.

Benefits of Getting Certified at dinaris.org

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the dinaris.org provides professionally designed online courses which are effective at training, and assist those with advancing their careers. The dinaris.org also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 111-1111 or send us an email at for more information.


Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, password, and username are emailed following order
  • 90 days of 24/7 access to individual training programs / 180 days for Professional Certification Program
  • Programs include voice-overs, easy navigation, progress checks, and high-quality animations
  • Course notes (in PDF) and/or references available with select training programs
  • Online final assessment with multiple-choice questions can be taken an unlimited number of times, until passing grade is achieved
  • A Certificate of Completion is immediately available once course requirements have been satisfied


The Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820 Course is Found in the Following Professional Certification Program(s):


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

COURSE OUTLINE:


INTRODUCTION
1. Welcome
2. Introduction
3. Reviews and Assessments

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

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

PRODUCTION ASSURANCE
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

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

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

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

CONCLUSION
41. Summary

COURSE OBJECTIVES:


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.

JOB POSTINGS:

608 Device Regulatory jobs found.
Displaying jobs #1-4.

Senior Device Developer – ASE 5
Posted Date: 2017-06-24
Kforce Technology – United States, CA, San Leandro, 94577

Director, Regulatory Affairs Promotional Materials
Posted Date: 2017-06-25
Pharmacyclics – United States, CA, Sunnyvale, 94091

Looking for a career in Medical Device Sales?
Posted Date: 2017-06-24
Medical Sales Recruiting – United States, AZ, Tucson, 85718

Packaging Engineer/ Medical Device/ Manufacturing
Posted Date: 2017-06-26
Confidential Client – United States, MI, Grand Rapids, 49953

See more Device Regulatory Jobs


For more information on the dinaris.org’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 111-1111, or email Support@BioPharmaInstitute.com.

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