Student Login |


Tuesday, June 15, 2021
Home » Medical Device Regulatory Affairs: Global Risk Management

Medical Device Regulatory Affairs: Global Risk Management (MDG3)

Certification Training
 
Rated 3.70/5
10 reviews
Method of Training: Online / Self-paced eLearning.
Credit Hours: 1 credits.
Duration: ~1 hour(s).
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the Biopharma Institute for more information.

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.

Online Training: The Benefits of Remote Learning & eLearning

  • Immediate access to training: Instructions, username, password, and receipt of payment are 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 for professional certification programs for 180 days.
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs.
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Purchase orders (POs) accepted: If a PO is required by your company, 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 provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization.

Contact Us:

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.

Information Request / Suggest a Course Form:

NAME:
COMPANY:
ADDRESS:
CITY:
STATE:
ZIP CODE:
COUNTRY:
PHONE:
EMAIL:
 
Enter the number from the image above
COMMENTS or Suggest a course:
(For pricing information, please provide us with as much detail as possible about your training project):