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Friday, March 29, 2024
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Medical Device Regulatory Affairs: Global Risk Management

Medical Device Regulatory Affairs: Global Risk Management Certification Training


Program/Course ID:MDG3
Enrollment Period:12 months.
Average Learning Time:~.
Additional Resources:Supplemental materials/activities.
Credit Hours:3 credits.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.

2024 UPDATE:
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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

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.

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Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

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