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:
Lernia did an excellent job. Your team handled the ambiguity very professionally. You helped shape and adjust the agenda, as the content and participant list came into focus. The deck and migration macro handout were on target, informative, and succinct. You guys rolled with the punches as true pros in your business. The training database was not ready, [but] you were ready with plan “b” without skipping a beat (used UAT). Thank you!
Last month the FDA released a draft guidance document, “Unique Device Identification: Direct Marking of Devices”, intended to help medical device labelers understand the FDA’s requirements for direct marking of…read more →