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Medical Device Micro -Training Courses

We offer a range of short, content rich, engaging courses. The courses range from 1 hour to 2 hours in length. Learn fast. Learn well.

Theses courses can be taken online, on-site or at a location near you. 

We can also customize our courses based on your specific training needs.

Photo of in-house classroom training workshop

COURSES

FDA Compliance Trends

One of the ways the FDA confirms compliance with quality regulations is through inspections and audits. The FDA inspects manufacturers of finished medical devices as well as suppliers of components, parts or accessories of devices. 

Warning letters are issued by the FDA if they find a medical device firm or individuals products, practices, processes, or other activities are in violation of the Food, Drug, and Cosmetic Act. The warning letter affords firms the opportunity to voluntarily take corrective action prior to the initiation of formal enforcement action.

In this course participants learn about FDA inspection trends and warning letters relating to recent software validation non-conformances. This is done by the review of warning letters where noncompliance to software validation requirements are cited.

If you want us to cover a particular topic just let us know and we can customize the course for you.

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

One of the ways the FDA confirms compliance with quality regulations is through inspections and audits. The FDA inspects manufacturers of finished medical devices as well as suppliers of components, parts or accessories of devices. 

Warning letters are issued by the FDA is they find a medical device firm or individuals products, practices, processes, or other activities are in violation of the Food, Drug, and Cosmetic Act. The warning letter affords firms the opportunity to voluntarily take corrective action prior to the initiation of formal enforcement action.

In this course participants learn about FDA inspection trends and recent warning letters relating to equipment and process validation non-compliances.

If you want us to cover a particular topic just let us know and we can customize the course for you.

Each short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

One of the ways the FDA confirms compliance with quality regulations is through inspections and audits. The FDA inspects manufacturers of finished medical devices and drugs as well as suppliers of components, parts or accessories of devices. 

Warning letters are issued by the FDA is they find a medical device firm or individuals products, practices, processes, or other activities are in violation of the Food, Drug, and Cosmetic Act. The warning letter affords firms the opportunity to voluntarily take corrective action prior to the initiation of formal enforcement action.

In this course participants learn about FDA inspection trends . This is done by the review of warning letters where noncompliance to design control  requirements are cited.

If you want us to cover a particular topic just let us know and we can customize the course for you.

Each short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

One of the ways the FDA confirms compliance with quality regulations is through inspections and audits. The FDA inspects manufacturers of finished medical devices and drugs as well as suppliers of components, parts or accessories of devices. 

Warning letters are issued by the FDA is they find a medical device firm or individuals products, practices, processes, or other activities are in violation of the Food, Drug, and Cosmetic Act. The warning letter affords firms the opportunity to voluntarily take corrective action prior to the initiation of formal enforcement action.

In this course participants learn about recent FDA inspection trends and warning letters. This is done by the review of warning letters where noncompliance to the quality system regulation requirements are cited.

Session is made highly interactive via use of practical examples / case studies. Contact us to request further details on this course.

Spotlight on ISO 13485:2016

This short course on ISO 13485:2016 is specifically designed for manufacturing professionals and  covers key topics and content on the requirements as covered in Section 7.5 – Production and Service provision.

If you want us to cover a particular topic just let us know and we can customize the course for you.

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

This course is specifically designed for ALL employees regardless of their work area. It focuses on the parts of the standard such as Section 4.2 – Documentation Requirements.

If you want us to cover a particular topic just let us know and we can customize the course for you.

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

Spotlight on Improving Problem Solving Skills

This short 5 Whys Analysis training course will take you through step by step how to use this important and widely used a problem solving tool.

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

This short training course takes you through the steps involved in constructing a fishbone diagram.

Fishbone analysis also known as cause and effect analysis was created by Kaoru Ishikawa. The analysis suggests that in order to solve a problem (or effect) an organisation should try to find out the causes behind the effect. Discovering all of the causes will help an organisation solve the problem and plan how to prevent the problem from reoccurring.

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

In a typical problem solving scenario there are often large volumes of data that need to be organised.

The Affinity Diagram or KJ Ho is a creative problem-solving methodology that is used to put somewhat unorganised / unstructured information and findings on a subject matter of interest into order.

This short course teaches participants how to use this simple but effective tool to organise a large volume of ideas.

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

In this course participants will learn how to write a problem statement. This is the first step when investigating any problem.

This short course teaches participants how to use this simple but effective tool to organise a large volume of ideas.

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

 

Spotlight on Lean Manufacturing Skills

When your employees first get introduced to lean manufacturing they may struggle with all the new terminology. But with time, education, application, and understanding, they will become a lean native.

This short course gives them a quick tour of the lean language landscape.  They will  learn a high-level overview of Lean. They will learn the basic principles of Lean, and will learn the  seven forms of waste. 

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

Kaizen is the way you improve the value stream. It’s practiced through a continuing series of workshops and projects. 

In this short course participants will learn what Kaizen is, how to practice Kaizen in their own organisation, and how to conduct Kaizen projects.

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

In this short course participants will learn how to determine what their customers value, and how to provide that value in the most effective way. The definition of value is important, because it forms the foundation upon which Lean processes are built, and it guides you in assembling activities in a continuous stream of value creation. In this short course participants lean the definition of value, and learn the lean standard definition of value. 

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

Spotlight on Soft Skills

Quality technicians have a unique and importance role in a medical device company. They are usually at the forefront of investigating quality issues and spotting improvement opportunities. They escalate quality issues. They attend engagement process meetings and quality  review meetings. These tasks require good communication skills. 

This short course teaches the tips and tricks on how to communicate effectively when working in a quality role in a medical device company.   

This short course is made highly interactive via use of practical examples. Contact us to request further details on this course.

Don’t see a training course that meets your requirements?

Contact us and tell us your training needs.  We can design a new course tailored made to meet your needs.