A Global Life Science Company (Top 10)

Retraining a global workforce to  address FDA warning letters

The Challenge:

Helping a global generics manufacturer address FDA warning letters  as the result of data integrity issues.

The Solution:

Deployed seven online training programs translated into fourteen different  languages to 28 manufacturing facilities in less than 9 months.

The Impact:

Successfully helped address the FDA warning letters and retrain more than  20K employees globally increasing overall quality, safety and compliance.

Roadmap to successful compliance training

The Challenge

The Solution

The Impact

The Challenge

Meeting global standards  through a harmonized online  training approach

A top-five global pharmaceutical generics manufacturer was  slapped hard by the FDA for problems at three manufacturing  facilities for ongoing data integrity issues.

The resulting corrective and preventive action (CAPA) required  retraining of their global workforce to help them address the  warning letters that were issued by the FDA.

Not only did the manufacturer have to retrain tens of  thousands of employees, but the program entailed  multi-lingual content delivered worldwide.

After a thorough evaluation LearnGxP was the clear choice over twelve other vendors for three main reasons:

The quality and alignment of our courses with the FDA regulations.
The compelling way the content was delivered maximizing learning principles.
Unparalleled customer support to ensure the project’s success.

The client was also impressed by LearnGxP’s knowledge and experience in the  life science sector something the other vendors did not have.

The Solution

An extension of their  training department

After a phase of initial consultation with the clients SME’s  it was decided to roll out the following online training  courses to satisfy the resulting CAPA from the warning letters from our existing library.

Laboratory Data Integrity
Current Good Manufacturing Practices (210,211)
Good Documentation Practices to Ensure Data Integrity
Corrective and Preventative Actions (CAPA)
Contamination Prevention & Control in a GMP Environment
The Principles of Process Validation
FDA Inspection Readiness

Our team worked closely with the client’s SME’s to customize  specific content to align more closely with their policies  and procedures and thus deliver more custom training.

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

VP Global Quality Learning

The Impact

Successfully addressed  FDA warning letters

The LearnGxP team delivered the final online courses,  including translations, in less than 9 months — a true success  for both parties. Today, more than 20,000 staff are fully  trained, and the client has successfully addressed the  warning letters issued by the FDA.

Following on from the success of this project the client  continues to work closely with LearnGxP continually  rolling out compliance training to their global workforce.

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