Risk Management Masterclass [2024] | Certification Course
Risk Management Masterclass [2024] | Certification Course, available at $69.99, has an average rating of 3.88, with 38 lectures, based on 121 reviews, and has 3101 subscribers.
You will learn about Become an expert in creating Risk Management documents from scratch, such as PFMEA, DFMEA, HAZOP, HACCP for any enterprise. Learn-depth on how to perform Risk Assessment, Risk Evaluation, Risk Measurement, Risk Control and Benefit-Risk Analysis! In-depth understanding of Regulatory standards for GMP environment such as ISO 14791:2019, EU 2017/745 MDR, 21 CFR 820, SOR/98-282, ISO13485 and ISO 22000 Be proficient in what Food and Drug Administration (FDA) auditors are looking for while doing Quality audits in medical device and food industry, 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 How Risk management Activities is essential in creating a good manufacturing practice (GMP) environment. This course is ideal for individuals who are Professionals looking to be promoted or looking to get into medical device, pharmaceutical industry and food industry It is particularly useful for Professionals looking to be promoted or looking to get into medical device, pharmaceutical industry and food industry.
Enroll now: Risk Management Masterclass [2024] | Certification Course
Summary
Title: Risk Management Masterclass [2024] | Certification Course
Price: $69.99
Average Rating: 3.88
Number of Lectures: 38
Number of Published Lectures: 38
Number of Curriculum Items: 38
Number of Published Curriculum Objects: 38
Original Price: $94.99
Quality Status: approved
Status: Live
What You Will Learn
- Become an expert in creating Risk Management documents from scratch, such as PFMEA, DFMEA, HAZOP, HACCP for any enterprise.
- Learn-depth on how to perform Risk Assessment, Risk Evaluation, Risk Measurement, Risk Control and Benefit-Risk Analysis!
- In-depth understanding of Regulatory standards for GMP environment such as ISO 14791:2019, EU 2017/745 MDR, 21 CFR 820, SOR/98-282, ISO13485 and ISO 22000
- Be proficient in what Food and Drug Administration (FDA) auditors are looking for while doing Quality audits in medical device and food industry,
- 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
- How Risk management Activities is essential in creating a good manufacturing practice (GMP) environment.
Who Should Attend
- Professionals looking to be promoted or looking to get into medical device, pharmaceutical industry and food industry
Target Audiences
- Professionals looking to be promoted or looking to get into medical device, pharmaceutical industry and food industry
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The most extensive course on Risk Management available in Udemy!
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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, pharmaceutical industry and any other enterprise that conducts risk management activity.
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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.
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By the end of this course you will be a pro at creating complex Risk Assessment and Risk Measurement documents such as PFMEA, DFMEA, HACCP, HAZOP, 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.
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You will be well versed in rules, regulations and standards for medical device industries across the world such as ISO14971 (Risk Management, ISO) , ISO13485, ISO 22000, 21CFR810 (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.
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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.
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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.
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Note: This course is directly related to and applies to Enterprise Risk Management (ERM). Medical device and Pharmaceutical companies are an enterprises themselves so this course teaches you everything you need to know to manage risks in an enterprise. In fact, you will learn risk management in so much in-depth from this course that you can tackle risk management activities on any enterprise.
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Note: This course also ties into Financial Risk Management (FRM) as we go in depth on the types of risks companies deals with, and financial risk is one of them. Hence students wanting to learn FRM can also greatly benefit from this course.
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Course Curriculum
Chapter 1: Introduction and Objective
Lecture 1: Introduction
Lecture 2: Course Objectives
Chapter 2: Fundamentals for Risk Management and Quality Management System
Lecture 1: What is Medical device, Pharmaceuticals and cosmetics?
Lecture 2: Laws and Standards for Medical device and Pharmaceuticals
Lecture 3: Quality Management System (QMS) overview
Lecture 4: What is Risk and kinds? Enterprise Risk, Financial Risk, Health Risk etc
Lecture 5: Risk Management- Overview
Chapter 3: Classes of Medical Device
Lecture 1: Classes of Medical Devices
Chapter 4: Quality Management Systems (QMS) standards from around the world
Lecture 1: Overview of QMS system and regulatory bodies
Lecture 2: QMS of Health Canada: SOR/98-282
Lecture 3: USA QMS for medical devices (21-CFR-820)
Lecture 4: QMS standard of Brazil: ANVISA- RDC 40/2015
Lecture 5: Europe QMS: EU 2017/745 (MDR)
Lecture 6: Japan QMS: PMDA- MHLW MO 169
Lecture 7: Australia QMS: Therapeutic Goods Administration (TGA)
Lecture 8: International Organization of Standardization (ISO) QMS: ISO 13485
Chapter 5: Risk Management (RM) System per ISO 14971 standards
Lecture 1: Intro to Risk Management Standard (ISO14971)
Lecture 2: Mandated RM documents per ISO 14971
Lecture 3: Risk Management Activities
Chapter 6: Complete & Compliant Risk Management File
Lecture 1: Types of documents used for RM activities
Lecture 2: Number of RM documents for one medical device
Lecture 3: Important terminologies in Risk Management & Risk Assessment
Lecture 4: Risk Measurement
Lecture 5: PFMEA- Understand and Create FMEA document from Scratch!
Lecture 6: Design FMEA (DFMEA) and User FMEA (UFMEA)- Create from Scratch!
Lecture 7: Benefit & Drawbacks of FMEA, FTA and PHA
Lecture 8: Risk Controls
Lecture 9: Benefit Risk Analysis
Lecture 10: Production and Post Production Activities
Lecture 11: Risk Management Report
Chapter 7: Bonus: A to Z on HAZOP Analysis. Create an entire HAZOP file from Scratch!
Lecture 1: Hazard and Operability Analysis (HAZOP)- Overview
Lecture 2: Four phases of HAZOP Study
Lecture 3: Guide Words on HAZOP study
Lecture 4: Learn to create a HAZOP file from Scratch!
Lecture 5: Advantages and disadvantage of HAZOP Analysis
Chapter 8: HACCP (Hazard Analysis Critical Control Points)- Bonus
Lecture 1: HACCP and seven principles of HACCP
Lecture 2: Identifying Critical Control Point (in HACCP) using Flow Chart
Lecture 3: Create HACCP plan from scratch!
Instructors
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Anil Sharma Kandel
Industrial and Manufacturing Engineer
Rating Distribution
- 1 stars: 6 votes
- 2 stars: 16 votes
- 3 stars: 23 votes
- 4 stars: 35 votes
- 5 stars: 41 votes
Frequently Asked Questions
How long do I have access to the course materials?
You can view and review the lecture materials indefinitely, like an on-demand channel.
Can I take my courses with me wherever I go?
Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!
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