Last updated 4/2023Course Language EnglishCourse Caption English [CC]Course Length 04:31:23 to be exact 16283 seconds!Number of Lectures 30
This course includes:
4.5 hours hours of on-demand video
Full lifetime access
Access on mobile and TV
Certificate of completion
4 additional resources
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.
Be proficient in what Food and Drug Administration (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
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. Who this course is for:Professionals looking to be promoted or looking to get into medical device or pharmaceutical industry
Sections are minimized for better readability, click the section title to view the course content
2 Lectures | 11:20
5 Lectures | 48:01
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
1 Lectures | 09:19
Classes of Medical Devices
Classes of medical devices, as defined by different regulatory bodies are defined. Also explained the differences between ISO Clean room class and medical device classes.
8 Lectures | 01:23:08
Overview of QMS system and regulatory bodies
QMS of Health Canada: SOR/98-282
Know about the rules and guidance set by Health Canada QMS for medical device. QMS Standard made public by Health Canada has been attached for reference. Students are required to check the latest version of standards before use.
USA QMS for medical devices (21-CFR-820)
Know about the rules and guidance set by US Food and Drug Administration for medical device. Attachment is a printed from taken directly from FDA website, open to public. Students are required to check the latest version of standards before official use.
QMS standard of Brazil: ANVISA- RDC 40/2015
ANVISA does not seem to publicly put out standards so standard document is not attached.
Europe QMS: EU 2017/745 (MDR)
Please visit EU official website for latest guidance and standards for EU 2017/745 (MDR) and EU 2017/746 (IVDR)
Japan QMS: PMDA- MHLW MO 169
Please visit Japan's official website for latest guidance and standards on PMDA MHLW MO 169 standards.
Australia QMS: Therapeutic Goods Administration (TGA)
Know about the rules and guidance set by Therapeutic good Association of Australia for medical device. Attached document is a public document provided by Australian for Risk Management Activities. Students are required to check the latest version of standards before use.
International Organization of Standardization (ISO) QMS: ISO 13485
Please visit ISO's official website for the preview of ISO 13485 standardstandards.
3 Lectures | 32:50
Intro to Risk Management Standard (ISO14971)
Please visit ISO official website (linked) to preview the overview of standards
Mandated RM documents per ISO 14971
Risk Management Activities
11 Lectures | 01:26:45
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!
Attached is the PFMEA template that I created from scratch. Sharing this template as reference.
DFMEA and UFMEA- Create from Scratch!
Refer to the template provided on PFMEA lecture to be utilized for practice and reference.
Benefit & Drawbacks of FMEA, FTA and PHA
Benefits and Disadvantage of using FMEA, PHA and Fault tree analysis (FTA) is discussed to help you understand which document is right for your organization.
Learn how to control the risk arising from process, design, tools and more in order to reduce risk to as low as possible.
Benefit Risk Analysis
What to with the residual risk after risk control measures have already been placed.
Production and Post Production Activities
Learn about post market surveillance (PMS) methods and how to use PMS data as an input into RM activity to make your RM process more robust and updated.
Risk Management Report
Learn the role of top management in Risk Management Activity and how to proceed is risk outweighs the benefit from the medical device
(4 course ratings)
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