Founded in 2000, Lernia Training Solutions specializes in the creation, delivery, and management of learning for the life science industry. We design customized training programs for companies of all sizes in order to help them meet regulatory requirements and business objectives, and have their employees equipped with working knowledge of the subject matter at hand.
Supporting UDI Initiatives
Lernia Training Solutions is announcing the release of a new eLearning module, UDI Overview. This 20-minute module introduces medical device colleagues to the recently approved FDA guidance on UDI by discussing the industry dynamics surrounding this topic and key considerations when planning the adoption of UDI.
For more information about this module, and to view a demo, visit our UDI page under the Services menu.
While creating regulatory compliance training solutions aimed at preparing learners to better perform their jobs, we also keep in mind organizational timeframes, resources, and budget constraints of our clients. As a result, we have built a client base of long-term customers and a strong referral network.
Regulatory Compliance Training
Over the last 14 years, Lernia has provided the following support for a variety of projects:
- Strategic Analysis and Planning
- Change Management and Communication Support
- Regulatory Compliance Training Design and Delivery
Many times these projects are cross- functional initiatives subject to regulatory timelines that require the implementation of IT systems and improved business processes. Our experience and industry acumen provide us with the expertise to excel at supporting these complex projects.
Sample cross- functional initiatives:
We recently completed a very important exercise [where we] conducted a production process simulation to glean information and feedback on the user experience, as well as training and business support materials. Karen led the training work stream and Marge supported her efforts. This included a comprehensive web-based training, a plethora of job aids and instructor-led training (virtual). Both Karen and Marge are to be commended for their commitment and hard work on the overall program and production process simulation. We appreciate their efforts and value their commitment to the success of the program.
Lernia Training Solutions has assisted several pharmaceutical companies in implementing their clinical trial data transparency initiatives. We have designed training for internal and external personnel in understanding the scope and…read more →