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Tuesday, December 11, 2018
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Medical Device Regulatory Affairs: Global Risk Management (MDG3)

Certification Training Duration: 1.5 hours (the average time to complete the training program, including final assessments).
Credits Hours: 1
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 $149.00

BioPharma Institute LogoTraining Program: Medical Device Regulatory Affairs: Global Risk Management
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 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. Course objectives are to train on the required documentation for risk management, to provide students with the knowledge necessary to calculate risk, and to convey an understanding of the process of risk management. This particular course is also included in the Global Medical Device Regulatory Affairs Professional Certification Program.

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 worked with many corporations by providing online training, and have offered significant contributions to the development of the biotechnology and healthcare business in general. Find out what BioPharma Institute can do for you and the needs of 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: Global Risk Management course is found in the following professional certification program(s):


Global Medical Device Regulatory Affairs Professional Certification Program: This Global Medical Device Regulatory Affairs Professional Certification Program is an online program which guides the student through a global medical device regulations overview. It discusses how ISO13485:200 … Learn more


COURSE OUTLINE:


INTRODUCTION
Welcome
Introduction
Assessment

OVERVIEW OF RISK MANAGEMENT
Glossary of Terms
Regulatory Standards and Guidance
ISO 14971:2007
The Concept of Risk
Risk Management Process
Roles and Responsibilities
Example of A Hazards And Consequences Analysis Review

RISK MANAGEMENT PROCESS
Introduction
Risk Management Planning
Probability and Severity Descriptors
Risk Analysis
Risk Evaluation Tools
Risk Estimation and Classification
Risk Mitigation
Risk Control
Post-Production Information
Documentation
Review

CONCLUSION
Summary

Glossary/Resources

COURSE OBJECTIVES:


Explain the terminology of risk management.
Identify the risk management process.
Identify how risk can be calculated.
Identify the documentation required for risk management.


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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