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Tuesday, December 11, 2018
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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
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Medical Device Regulatory Affairs.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

BioPharma Institute LogoTraining Program: Medical Device Quality Management: Managing a QMS
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

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 BioPharma Institute

The BioPharma Institute 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) 424-6576 or send us an email at support@biopharmainstitute.com 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, user name, password and receipt of payment 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 training: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


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.


For more information on the BioPharma Institute’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) 301-8370, or email Support@BioPharmaInstitute.com.

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