מחזור 3.0 - קורס הכשרה למהנדסי איכות במכשור רפואי

14 אוגוסט, 2019

ג'יסאפ פותחת מחזור 3.0:  קורס הכשרה למהנדסי איכות במכשור רפואי

:הקורס יתקיים בתאריכים
חמישה ימי שלישי עוקבים בחודשים נובמבר דצמבר 2019
5.11, 12.11, 19.11, 26.11, 3.12
שעות הקורס: 15:00 -9:00

 

סילבוס – קורס מהנדסי איכות מכשור רפואי /נובמבר  2019

  • Day 1 – Quality System Requirements

    1. Culture for Quality & Quality system
      • General requirements, Scope & Definitions
      • Document and Record controls (DHF, DMR, DHR, QMS records)
    2. Management
      • Management responsibility, Resource management, Quality reviews
    3. Purchasing controls
      • Purchasing process, Purchasing information, Evaluation and selection of suppliers
      • Acceptance sampling inspection principles
    4. Production and Service provision
      • Production & service control, Process Verification and Validation, Measuring equipment
      • Statistical Process Control (SPC) principles

    Day 2 – Design Controls and Risk Management

    1. Design controls
      • Design planning and development, Customer related processes
      • Design verification and Product validation
    2. Risk management
      • ISO 14971: Overview, Terms and definitions, requirements
      • Risk management practices & tools (including dFMEA and pFMEA)

     

    Day 3 – MDSAP Audit

    1. MDSAP – Medical Device Single Audit Program
      • Fundamentals, Scope of the MDSAP audit
      • Nonconformity grading and reporting
      • Difference between MDSAP and other medical device quality audits
      • How to conduct the audit? How to prepare for the audit?
    2. Monitoring and Feedback
      • Nonconforming product
      • Complaint handling
      • Corrective and Preventive Action (CAPA)

     

    Day 4 – Principles on Medical Devices Regulations – EU (MDR)

    • Medical device classification according to Europe regulations
    • Principles of MDR and communication with Notified Bodies

     

    Day 5 – Principles on Medical Devices Regulations – USA (21CFR820)  

    • Medical device classification according to US regulations
    • Principles of US medical device regulations and communication with FDA
    • Course Exam

     

 

להרשמה http://tiny.cc/GsapMDCourseV3