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.
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
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.
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.
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