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Tuesday, June 27, 2017
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Medical Device Quality Management: Managing a QMS (MDQ1)

Certification Training Duration: 2 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 $199.00

dinaris.org LogoTraining Program: Medical Device Quality Management: Managing a QMS
Training Provided By: dinaris.org
Website: http://dinaris.org

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

This course teaches the student about the maintenance of a quality management system (QMS). Course objectives include training how to recognize the importance of measuring performance, illustrating how the internal audit affects the management role in the QMS, describing the elements of a quality audit program, conveying the responsibilities of quality management roles, and listing the key characteristics of a QMS. The course includes an introduction and topics covering quality audits, management responsibility, a detailed quality management system overview, how to measure performance, and a conclusion which reviews the previously listed topics with clarification of resources and terminology.

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

The dinaris.org has significant expertise in managing large training projects. Our aim is to assist professionals with uncovering new discoveries and furthering their understanding of the industry and the peripheral technologies within it. Contact us today to find out what we can do for you and your company.

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 Quality Management: Managing a QMS Course is Found in the Following Professional Certification Program(s):


Medical Device Quality Management Professional Certification Program: This online certification program supplies an introduction to the requirements of a Corrective and Preventive Action (CAPA) system; provides a description of how to identify existing problems, correct them, and … Learn more

COURSE OUTLINE:


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

QUALITY MANAGEMENT SYSTEM OVERVIEW
4. Overview
5. Key QMS subsystems within ISO13485
6. Key QMS subsystems within CFR820
7. Regulatory requirements
8. Maintenance of a QMS
9. Topic review

MANAGEMENT RESPONSIBILITY
10. Overview
11. Management compliance responsibility
12. Periodic management review
13. Overview of QMS roles and responsibilities
14. Management responsibilities
15. The management representative
16. Topic review

QUALITY AUDITS
17. The role of audits in a QMS
18. Setting up an internal audit program
19. Key requirements for internal audits
20. The five steps of internal audits
21. Commitment tracking
22. Topic review

MEASURING PERFORMANCE
23. Overview
24. Monitoring and measurement
25. Sources of data
26. Statistical techniques
27. Improvement
28. Topic review

CONCLUSION
29. Summary

GLOSSARY/RESOURCES

COURSE OBJECTIVES:


–List the key characteristics of a QMS.
–State the responsibilities of quality management roles.
–Describe the elements of a quality audit program.
Relate how the internal audit affects management role in the QMS.
–Recognize the importance of measuring performance.

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

Medical Device Sales Representative
Posted Date: 2017-06-24
Hiossen Inc – United States, FL, Tampa, 33646

Medical Device Laboratory Technician (Lab Tech)
Posted Date: 2017-06-23
Medix – United States, IL, Mundelein, 60060

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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