A Global Medical Device Manufacturer (Top 10)

How our partnership helped streamline regulatory and compliance training

The Challenge:
Our client is a leading global medical device manufacturer who was looking for a better way to ensure their employees stay up to date with the latest regulations within the medical device sector both in the US and internationally. With the ever-changing regulations and an already stretched training department our client wanted to partner with a life science training company who would be able to work with them to deliver continuous training to ensure ongoing regulatory compliance for their workforce.
The Solution:
Our team worked closely with the client to deliver specific accredited online training from our library to satisfy the various regulatory requirements from the US, Europe and China. We were also able to work closely with the client to customize various elements of our training to align specifically with their own specific policies and procedures. The solution was a true partnership.
The Impact:
Our solution was directly incorporated into the client’s mandatory training plans for employees to mitigate any potential non-conformances from audits thus satisfying 21 CFR 820.25(b) to a higher degree.

Taking the pain our of regulatory training

The Challenge

Keeping up to date with ever changing regulations

Before working with our team of dedicated life science specialists the client struggled in the following areas.

  1. The inability to access subject matter experts to create the necessary content.
  2. The time and effort it would take to manage a project of this nature.
  3. The lack of technical resources in-house such as instructional designers, graphics designers and voice over artists.
  4. How long it would take to build a comprehensive library of online training?
  5. Who would manage and update the training when necessary?
  6. Who would know what regulations change and when?

Having evaluated other vendors and assessed the time and cost of trying to develop material in-house Learnaboutgmp was chosen as the partner of choice to help bridge the regulatory and compliance training gaps.

The Solution

Online training aligned with the client's specific requirements

Working with the client’s training department we created a strategy framework around their QMS to analyze what areas they needed to focus their training on initially. Through this initial framework we were able to map our courses and microlearning videos to their specific SOPs and Work Instructions.

With this work complete we were able to create a clear three-month online training strategy to focus on key areas of the business where they most needed help.

We were then able to roll a series of accredited courses, learning paths and microlearning videos to continually upskill their workforce.

In this three-month period we focused on the following topics:

  1. 21 CFR Part 820
  2. ISO 13485:2016
  3. MDSAP
  4. Process Validation
  5. (CFDA’s) – GMP for Medical Devices

Throughout this initial period our weekly strategy alignment calls ensured the client stayed on track and met their training goals.

I've been in quality and operations with medical device companies for 20+ yrs and this is the first site/program to ever offer all this information and training in one easy to use place for companies to access. You are truly providing an amazing service!


The Impact

Required training for QA and other departments

Following on from a highly successful twelve-month training rollout our client immediately recognized the impact our training was having helping their workforce not only stay in compliance but also do their jobs better.

The clients QA department was quick to make our training a mandatory part of their overall training strategy and we continually work with them to today to help with enhance cross departmental training. With their ability to feed directly into our course development roadmaps we have become a true partner to their operations.

Here’s why 50,000+ learners use 
our training to stay compliant

I've been in quality and operations with medical device companies for 20+ yrs and this is the first site/program to ever offer all this information and training in one easy to use place for companies to access. You are truly providing an amazing service!

Director Learning & Development

Medical Device Company (Top 20)

Every course was given a huge thumbs up by our internal Quality Systems leaders. I highly recommend using LearnGxP for any organization interested in deploying top notch GMP related courseware.

VP Global Quality Learning

Global Pharmaceutical Company (Top 5)

Each course has been developed to the highest of standards with content that each learner can relate to easily. Thank you for assisting us in executing great online learning solutions!

Associate Director Learning & Development

Global Biotechnology Company (Top 5)

Your online courses provide excellent regulatory compliance knowledge as well as effective training using scenarios and case studies.

Technical Training Manager

Global Generics Manufacturer

Courses are available to perform in your own time and are split into manageable sections meaning that they can easily be completed around your busy schedule.

Laboratory Manager

Global Healthcare Company (Top 10)

I'm excited we’ve implemented LearnGxP as our internal training platform! Their compliance and regulatory training solutions are up-to-date and engaging, with videos and games to help us learn the material and make it stick.

General Manager

Life Science Service Provider

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