Be an expert in Risk Management (ISO 14971) and QMS (ISO 13485) activities and create PFMEA, DFMEA, CEA, PHA like a pro!
What you will 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
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.
English
language
Content
Introduction and Objective
Introduction
Course Objectives
Fundamentals for Risk Management and Quality Management System
What is Medical device, Pharmaceuticals and cosmetics?
Laws and Standards for Medical device and Pharmaceuticals
Quality Management System (QMS) overview
What is Risk?
Risk Management- Overview
Classes of Medical Device
Classes of Medical Devices
Quality Management Systems (QMS) standards from around the world
Overview of QMS system and regulatory bodies
QMS of Health Canada: SOR/98-282
USA QMS for medical devices (21-CFR-820)
QMS standard of Brazil: ANVISA- RDC 40/2015
Europe QMS: EU 2017/745 (MDR)
Japan QMS: PMDA- MHLW MO 169
Australia QMS: Therapeutic Goods Administration (TGA)
International Organization of Standardization (ISO) QMS: ISO 13485
Risk Management (RM) System per ISO 14971 standards
Intro to Risk Management Standard (ISO14971)
Mandated RM documents per ISO 14971
Risk Management Activities
Complete & Compliant Risk Management File
Types of documents used for RM activities
Number of RM documents for one medical device
Important terminologies in Risk Management
Risk Classification Table (Severity of harm *Probability of occurrence of harm)
PFMEA- Understand and Create on from Scratch!
DFMEA and UFMEA- Create from Scratch!
Benefit & Drawbacks of FMEA, FTA and PHA
Risk Controls
Benefit Risk Analysis
Production and Post Production Activities
Risk Management Report