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Home » Medical Device Quality Management: Managing a QMS

Medical Device Quality Management: Managing a QMS (MDQ1)

Certification Training
 
Rated 3.77/5
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Duration: 2 hours, Online (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. BioPharma Institute Reviews

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.

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.

All Courses in the Medical Devices Catalog:


Medical Device Regulatory Affairs: Australian Overview: This online program is an overview of Australian regulatory affairs. The course objectives are to describe the systems of classification for medical devices; define the roles of the regulator, manufacturer, and ... Learn more

Medical Device Regulatory Affairs: Australian Requirements for Registration: This is an online program offers training with immediate access upon enrollment. The students will be introduced to the specifics that are required before a medical device is qualified to go to market. The prog ... Learn more

Medical Device Regulatory Affairs: Global: This is an online program offering training with immediate access upon enrollment. Medical devices are globally regulated by a series of regulations and rules designed to produce an effective and safe device. T ... Learn more

Medical Device Regulatory Affairs: Global Quality Management Systems, the Requirements: This course details the regulatory expectations for quality management system (QMS) certification, identifies vital elements of the essential and standard administration roles, and explains how ISO 13485:2003 ( ... Learn more

Medical Device Regulatory Affairs: Global Risk Management: This online program explains relevant risk management terminology. The course identifies the process of risk management, details all of the documentation required, and discusses how risk can be calculated. Cour ... Learn more

Medical Device Quality Management: Managing a QMS: 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 inte ... Learn more

Medical Device Quality Management: Documentation and Records: Control, implementation, and development of documentation and records provide the foundation of a quality management system (QMS). It also provides the evidence of compliance with the FDA CFR 820 Quality System ... Learn more

Medical Device Quality Management: CAPA Systems: The ability to correct and identify existing problems and implement controls to prevent potential problems is essential for efficient quality management processes, safety products, and continued customer satisf ... Learn more

Medical Device Regulatory Affairs: US Overview: The medical device industry in the USA is governed by a number of important regulations, the most important of those being contained within the CFRs (code of federal regulations) - 21 CFR part 800 series. This ... Learn more

Medical Device Regulatory Affairs: US Quality Systems Requirements, 21 CFR 820: 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 ... Learn more

Medical Device Regulatory Affairs: US 510(k) Premarket Notification Scheme: This course introduces the student to the required activities necessary before a device is ready to go to market in the United States. The US Regulatory Affairs Overview (MDU1) course is recommended as an intro ... Learn more

An Introduction to the Regulation of Medical Devices: This program provides an introduction to the basics of medical device regulation, especially the requirements that manufacturers must meet in order to market devices in Europe and the USA. We explain what me ... Learn more

Online Training: The Benefits of eLearning

  • Immediate access to training: Instructions, username, 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 courses: 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
  • Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Purchase orders (POs) accepted: If POs are required, 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 offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization

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