Risk Management & Qms For Medical Devices Iso 14971 & 13485.

Be an expert in Risk Management (ISO 14971) and QMS (ISO 13485) activities and create PFMEA, DFMEA, CEA, PHA like a pro!

What you'll learn

Become an expert in creating Risk Management documents from scratch, such as PFMEA, DFMEA, FTA, PHA etc for Medical device and Pharmaceutical companies.

In-depth understanding of Regulatory standards such as ISO 14791:2019, EU 2017/745 MDR, 21 CFR 820, SOR/98-282 and ISO13485.

Proficient in what FDA auditors are looking for while doing Quality audits for Risk Management activities

Learn why CAPA, Non conformances, IQ/OQ/PQ, complaint handling process are crucial for medical device industry

Learn in-depth about Quality Management system (QMS) regulations from different countries around the world

Requirements

No prerequisite required. Course progresses from basic to advanced level with easy to grasp content and real world examples.

Description

This course is designed to teach you everything that you need to know to become a Subject Matter Expert (SME) in Risk Management  and Quality Management System (QMS) within Medical device and Pharmaceutical industry. Regardless of your current skills and experience, after taking this course, you will be comfortable communicating to experts in medical device industry about Quality management systems (QMS) and risk management (RM) standards and regulations. You will learn how to draft complex RM documents such as PFMEA, DFMEA, Benefit-Risk Analysis, Post Market Surveillance Report (PMSR), Clinical Effects Analysis Report (CEA) from the scratch! Knowing this skills will set you apart from the crowd and you can easily land you six-figure jobs in a reputed medical device companies.You will be well versed in rules, regulations and standards for medical device industries across the world such as ISO 14971 (Risk Management, ISO) , 21 CFR 810 (FDA, USA), RDC 40/2015 (Anvisa, Brazil), EU 2017/745 MDR, MHLW MO 169 (PMDA, Japan) and TGR 2002 (TGA, Austrialia) and be able to talk about them in meetings, interviews and even with auditors.You will learn how processes like complaint reviews, Corrective and Preventative Maintenance (CAPA), Process Validation (PV), Equipment Qualification (IQ/OQ/PQ) ties into Risk Management and why companies need to do these activities.Whether you are just getting into Risk Management, or wants to freshen up your skills, or are looking to advance your career in the field, this course can provide you with more than enough knowledge to be the top 5% in your organization.

Overview

Section 1: Introduction and Objective

Lecture 1 Introduction

Lecture 2 Course Objectives

Section 2: Fundamentals for Risk Management and Quality Management System

Lecture 3 What is Medical device, Pharmaceuticals and cosmetics?

Lecture 4 Laws and Standards for Medical device and Pharmaceuticals

Lecture 5 Quality Management System (QMS) overview

Lecture 6 What is Risk?

Lecture 7 Risk Management- Overview

Section 3: Classes of Medical Device

Lecture 8 Classes of Medical Devices

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

Lecture 9 Overview of QMS system and regulatory bodies

Lecture 10 QMS of Health Canada: SOR/98-282

Lecture 11 USA QMS for medical devices (21-CFR-820)

Lecture 12 QMS standard of Brazil: ANVISA- RDC 40/2015

Lecture 13 Europe QMS: EU 2017/745 (MDR)

Lecture 14 Japan QMS: PMDA- MHLW MO 169

Lecture 15 Australia QMS: Therapeutic Goods Administration (TGA)

Lecture 16 International Organization of Standardization (ISO) QMS: ISO 13485

Section 5: Risk Management (RM) System per ISO 14971 standards

Lecture 17 Intro to Risk Management Standard (ISO14971)

Lecture 18 Mandated RM documents per ISO 14971

Lecture 19 Risk Management Activities

Section 6: Complete & Compliant Risk Management File

Lecture 20 Types of documents used for RM activities

Lecture 21 Number of RM documents for one medical device

Lecture 22 Important terminologies in Risk Management

Lecture 23 Risk Classification Table (Severity of harm *Probability of occurrence of harm)

Lecture 24 PFMEA- Understand and Create on from Scratch!

Lecture 25 DFMEA and UFMEA- Create from Scratch!

Lecture 26 Benefit & Drawbacks of FMEA, FTA and PHA

Lecture 27 Risk Controls

Lecture 28 Benefit Risk Analysis

Lecture 29 Production and Post Production Activities

Lecture 30 Risk Management Report

Professionals looking to be promoted or looking to get into medical device or pharmaceutical industry