Risk Management Masterclass [2023] | Certification Course

سرفصل های دوره

Be an expert in ISO 14971 (RM) and ISO 13485 (QMS). Create risk assessment docs like DFMEA, HAZOP, HACCP from scratch

1. Introduction and Objective

1. Introduction

2. Course Objectives

2. Fundamentals for Risk Management and Quality Management System

1. What is Medical device, Pharmaceuticals and cosmetics

2. Laws and Standards for Medical device and Pharmaceuticals

3. Quality Management System (QMS) overview

4. What is Risk

5. Risk Management- Overview

3. Classes of Medical Device

1. Classes of Medical Devices

4. Quality Management Systems (QMS) standards from around the world

1. Overview of QMS system and regulatory bodies

2.1 Health Canada website for Medical Device Regulations.html

2.2 Health Canada SOR-98-282.pdf

2. QMS of Health Canada SOR98-282

3.1 CFR - Code of Federal Regulations Title 21.pdf

3.2 FDA website for 21 CFR 820.html

3. USA QMS for medical devices (21-CFR-820)

4.1 Brazil- ANVISA RDC 402015 website.html

4. QMS standard of Brazil ANVISA- RDC 402015

5. Europe QMS EU 2017745 (MDR)

6. Japan QMS PMDA- MHLW MO 169

7.1 ARGB-Appendix-11-Risk-Management (Austrialia).pdf

7. Australia QMS Therapeutic Goods Administration (TGA)

8. International Organization of Standardization (ISO) QMS ISO 13485

5. Risk Management (RM) System per ISO 14971 standards

1.1 ISO 14971 website.html

1. Intro to Risk Management Standard (ISO14971)

2. Mandated RM documents per ISO 14971

3. Risk Management Activities

6. Complete And Compliant Risk Management File

1. Types of documents used for RM activities

2. Number of RM documents for one medical device

3. Important terminologies in Risk Management

4. Risk Classification Table (Severity of harm Probability of occurrence of harm)

5.1 PFMEA and DFMEA.xlsx

5. PFMEA- Understand and Create on from Scratch!

6. DFMEA and UFMEA- Create from Scratch!

7. Benefit And Drawbacks of FMEA, FTA and PHA

8. Risk Controls

9. Benefit Risk Analysis

10. Production and Post Production Activities

11. Risk Management Report

139,000 تومان

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تولید کننده: Udemy-Training