Learning Outcomes

Introduction to 21 CFR Part 820

21 CFR Part 820 - Subparts B to G

21 CFR Part 820 - Subparts H to O

Lesson Summary

This module introduces you to  21 CFR Part 820. It will teach you the importance of having a QMS in the medical device manufacturing industry and explain all fifteen subparts of 21 CFR Part 820 concisely.

Simplifying the Subparts of 21 CFR Part 820

ISO 13485 vs. 21 CFR Part 820

FDA Inspections - What are Their Types and How to Prepare for Them?

In this module, you will receive a simplified explanation of all the subparts of 21 CFR Part 820 and the conditions necessary for their compliance. You will also learn to compare ISO 13485 with 21 CFR Part 820. The module also discusses different types of FDA inspection and how you can eventually prepare for them.

21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR) - Course Assessment

Acquire a straightforward interpretation of the 21 CFR Part 820 standard for QSR in the US medical device industry.

21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR)

Medical device manufacturers willing to produce or place their products in the US market must comply with a regulatory standard called 21 CFR Part 820. If you are a regulatory professional working in this niche, enrolling in this course will give you a solid understanding of this standard. With this course, you will clearly learn about each subpart of the standard. It will also prepare you for the FDA inspection and related procedures.

The medical device market in the USA is lucrative but tightly regulated and controlled. The standard that controls the manufacturing and marketing of medical devices in the US market is known as 21 CFR Part 820. Created by the FDA, this regulation requires medical device manufacturers to develop a Quality Management System.
Using their expertise in the regulatory market, the course development experts at Exoexcellence Consultants have developed this course that explains all the major and minor aspects of 21 CFR Par 820. Comprising two modules, this course has been designed for Alison students interested in regulatory affairs, especially the ones concerned with medical device manufacturing. This course will also help professionals already in this field by upscaling their skills.
The first introduces the learners to the standard and explains all its subparts. It also discusses the importance of a robust QMS for the medical device manufacturing industry. The second module helps students revise all the subparts in a simplified way. Then, it explains the methods medical device manufacturers use to show compliance with 21 CFR Part 820. This module also compares ISO 13485 with 21 CFR Part 820. It also explains how manufacturers can prepare themselves for the FDA inspection process. By taking this course, students can not only establish themselves by upgrading their skills, but they can also work as regulatory consultants for medical device manufacturers,

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Safeguarding and Reporting

Safeguarding Vulnerable Adults

Impact of Abuse and Trauma

Creating Safe Environments and Policies

Communication, Trust, and Multi-Agency Collaboration

This module will introduce you to various professional safeguarding strategies for protecting children and vulnerable adults. You'll explore the causes and impacts of different forms of abuse and trauma. We'll show you how to create a safe environment for children and vulnerable adults cohesively and protect them from harm.

Safeguarding Children and Vulnerable Adults - Course assessment

Empower yourself to safeguard vulnerable individuals, fostering a secure community with this free online course.

Safeguarding Children and Vulnerable Adults

Have you ever felt a personal calling to make a difference in the lives of others? Have you thought of safeguarding vulnerable individuals? This course explores the various forms of abuse, their immediate and long-term signs and how they impact the lives of vulnerable individuals. Discover how to ensure a safe environment for children and vulnerable adults using collaborative approaches and the fundamental principles of safety and well-being

Topic 1: Introduction to Child Protection

Topic 2: International, Regional and National Legal Framework

Topic 3: Alternative Care and Child Safeguarding

Topic 4 : Monitoring and Evaluation in Child Protection

In this module, you will learn the fundamental concepts, guiding principles, and ethical considerations related to child protection before considering the international, regional, and national legal frameworks. We discuss the current approaches to prevent and respond to child abuse or neglect, including the signs of abuse, neglect, or violence.

Comprehensive Child Protection Training Course - Course Assessment

Learn the skills to prevent and respond to child abuse, neglect, exploitation and violence in this free online course.

Comprehensive Child Protection Training 

This online child protection course equips students with the knowledge and skills to identify, prevent, and respond to child abuse and neglect. You will learn to recognise signs of abuse, understand strategies for prevention and response to violence against children such as INSPIRE, and apply best practices for intervention and support. The course empowers learners to play a critical role in safeguarding children and promoting their well-being.

The Importance of Safe Food Handling - Part 1

The Importance of Safe Food Handling - Part 2

Organized Efforts for Food Safety

The ServSafe Examination

ServSafe Manager Certification - Sample Questions

This module teaches you about the fundamentals of safe food handling and different ways to prevent food contamination. It also talks about the global efforts concerning food safety and the role of the ServSafe certification program. Moreover, you will also be equipped with the essential knowledge to prepare yourself for the ServSafe exam.

Fundamentals of Serving Safe for Food Handlers - Assessment

This course will describe the methods of protecting food from getting contaminated and the basics of the ServSafe exam.

Fundamentals of Serving Safe for Food Handlers

Safe and hygienic food handling is extremely important to prevent contamination and diseases. This holds especially true for the professionals in the culinary sciences and food management field. Through this course, we have emphasized various areas and practices concerned with the safe handling of foods. We have also focused on the global efforts to ensure food safety along with the ServSafe certification and its various aspects.

Topic 1 : WorkSafeBC Regulations

Topic 2 : Responsibilities of Employers and Workers

Topic 3 : Handle Hazardous Materials Safely

Topic 4: Information to Be Disclosed on an SDS

Topic 5: WHMIS Education and Training

Workplace Hazards and WHMIS: A Guide to Safety and Legal Duties - Assessment

This free online course covers the laws and rules that must be complied with to guarantee safe and healthy workplaces.

Workplace Hazards and WHMIS: A Guide to Safety and Legal Duties

Are you aware of the laws protecting you from hazardous substances at work? This course covers essential regulations, including the Workers' Compensation Act, WorkSafeBC policies, and the Workplace Hazardous Materials Information System (WHMIS). Learn about employer and worker responsibilities, safe handling of hazardous materials, and the must-know guidelines that keep workplaces safe. Gain critical knowledge to protect yourself and others.

Introduction to Epilepsy

Diagnosing and Classifying Epilepsy with EEG

This module will demonstrate how to run simulations of six neurophysiological phenomena using simulation software known as MetaNeruon. It will also discuss the neurological conditions underlying epilepsy and how to use an EEG to diagnose this mental disorder.

Understanding Epilepsy - Course Assessment

This free online course takes you through the symptoms, classifications, diagnosis and treatment of epilepsy.

Understanding Epilepsy

Most of the world’s roughly 50 million epileptics do not have access to treatment, medical attention or even information about their neurological disorder. This free online course identifies who is most susceptible to epilepsy and explains its causes and symptoms. We then examine the available tools for diagnosis and treatment and demonstrate the use of the electroencephalogram (EEG) to detect this long-misunderstood condition.

Understanding Defensive Driving Principles

Vehicle Dynamics and Handling

Defensive Observation and Safe Following Distance

Traffic Laws, Regulations and Vehicle Maintenance

In this module, you’ll be introduced to the key concepts of defensive driving and its benefits. We emphasize the importance of anticipating potential hazards and making proactive decisions to avoid accidents. We show you how to use headlights correctly, avoid driving in blind spots, maintain a safe following distance and more.

Defensive Driving in Adverse Weather and Nighttime

Managing Space and Visibility

Defensive Driving in Different Environments

Managing Driver Fatigue and Distractions

In this module, you’ll learn about vehicle dynamics and handling. We discuss the role of weight distribution, suspension, speed, and vehicle design in affecting stability. We also provide some basic and advanced braking techniques, such as gradual braking, threshold braking, engine braking, and more.

Handling Emergency Situations

Crash Avoidance Maneuvers

Post-Crash Procedures and First Aid

In this module, you’ll gain insights into emergency braking, types of braking systems, and adapting techniques to varied road conditions. You’ll learn about the types of skids and their effective control measures. We show you how to communicate effectively with emergency services and administer basic first aid and cardiopulmonary resuscitation.

Comprehensive Guide to Defensive Driving - Assessment

Equip yourself with the skills and techniques to avoid accidents and stay safe on the road with this free online course.

Comprehensive Guide to Defensive Driving

Driving is an essential aspect of our lives but carries various risks. Defensive driving is, therefore, essential for ensuring road safety while driving. This course aims to enhance your driving skills and minimize the chances of accidents by providing guidance on observing road conditions, anticipating dangers, maintaining vehicle control and more. Are you ready to become a safer driver? Enrol now and learn for free!

Introduction to Domestic Violence and Abuse

The Components of Domestic Violence

Domestic Violence on Victims

Domestic Violence and Abuse on Children

Risks of Domestic Violence and Abuses on Children

Supporting the Victim and Reporting Incidents

This module will give you a broader understanding of domestic abuse and violence. We look at the signs of abuse in a relationship, the cycle of abuse and patterns of behaviour and the Duluth Model. This module briefly looks at the impact of domestic abuse on children as well as how to recognise and help victims of domestic abuse and violence.

Course Assessment

In this free online course, learn about identifying and reporting domestic violence and abuse in children and adults.

Fundamentals of Domestic Violence and Abuse

Domestic violence is common and many adults and children experience some sort in their lifetime. This course examines how to report abuse and explores the signs of abuse in a relationship. We will discuss different types and what to do if you suspect that a child is being abused. You will also learn how to help adults and children affected by domestic violence. Additionally, you will know how to report an incident in confidence.