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Tuesday, December 11, 2018
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Medical Device Regulatory Affairs: Australian Overview (MDA1)

Certification Training Duration: 1.7 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 $169.00

BioPharma Institute LogoTraining Program: Medical Device Regulatory Affairs: Australian Overview
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment.

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 the sponsor; and to identify the essential principles. This course includes introduction and sections on the essential principles, Australian regulations, classification and conformity, roles, and a conclusions that reviews the previously listed topics. This course is a part of the Australian Medical Device Regulatory Affairs Professional Certification Program.

Once all course requirements have been satisfied, a certificate of completion is immediately available. Course takers can take 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 is an online learning solution for professionals working within the healthcare, biotech, and pharmaceutical industries. Through the years, we have compiled a comprehensive offering of online books, recorded seminars, live seminars, and other tools used in our online courses to teach the various aspects of applications and precise job functions found within these industries. We are proud to serve thousands of corporations, both abroad and within the United States, and can be a trusted ally to 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 Regulatory Affairs: Australian Overview course is found in the following professional certification program(s):


Australian Medical Device Regulatory Affairs Professional Certification Program: The Australian Medical Device Regulatory Affairs Professional Certification Program will introduce to students the activities that are required before a medical device is ready to go to the Australian market.Th … Learn more


COURSE OUTLINE:


INTRODUCTION
1. Welcome
2. Overview
3. Assessment

AUSTRALIAN REGULATIONS
4. Medical Device Industry
5. Historical Perspective

THE ESSENTIAL PRINCIPLES
6. Introduction
7. the Essential Principles Checklist
8. Specific Essential Principles
9. Applying the Essential Principles
10. Review

ROLES
11. Introduction
12. Manufacturer Responsibilities
13. Sponsor Responsibilities
14. TGA Responsibilities
15. Review

CLASSIFICATION AND CONFORMITY
16. Medical Device Classification
17. Conformity Assessment
18. Review

CONCLUSION
19. Summary

COURSE OBJECTIVES:


Identify the Essential Principles.
Define the roles of the sponsor, manufacturer, and regulator.
Describe the classification systems of medical devices.


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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