Expert training for healthcare, with emphasis on the diagnostic laboratory.

Expert training for healthcare, with emphasis on the diagnostic laboratory.

Regulatory

LDT Phase I-II: Leadership & Training

LDT Phase 1& II from Laboratory Learning Solutions on Vimeo. Leadership This role of leadership is to support the team, direct the organization, remove any obstacles within the path of change and provide the necessary resources. Leadership commitment is key to ensure a quality structure that will sustain the initiative and provide ongoing support. Leadership commitment […]

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LDT Phase IV-V: Design Control & Process Control

LDT Phase IV Design Controls & V Process Controls from Laboratory Learning Solutions on Vimeo. The development a robust QMS initially begins with the understanding of policies and procedures that adhere to the 12 Quality System Essentials. Secondly, through the application of design controls, we include all aspects of test development, review, verification and manufacture. The

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LDT Introduction & Background

LDT Introduction from Laboratory Learning Solutions on Vimeo. In this module, you will learn the background and the issues surrounding laboratory developed tests to include prior patient safety incidents. We discuss the FDA 2014 draft guidance in alignment with FDA regulatory requirements of 21 CFR 820 design control and will outline the rationale for the

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