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

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

Regulatory

LDT Phase VII: Development of a Quality Management System

LDT Phase VII QMS Development from Laboratory Learning Solutions on Vimeo. The goal of a regulatory QMS framework is to develop and implement a proven model with the adoption and development of the appropriate polices, processes, and procedures that address each specific standard and requirement to include the following: 12 QSE 21 CFR 820 Design

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LDT Phase VI: Process Validation

LDT Phase VI Validation from Laboratory Learning Solutions on Vimeo. Process validation will ensure the effectiveness of the framework, all tasks and activities meet the requirements in comparison to federal regulation requirements and the LDT test development framework operates as intended. A validation protocol is useful to determine the system capability to manage high variation, low

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LDT Phase V: Stage Gate

LDT Phase V Stage Gate from Laboratory Learning Solutions on Vimeo. Stage Gate is a product development methodology that successfully addresses every detail of a new product from idea to launch. The steps are determined and each gate is assigned a process owner that will manage a list of tasks and activities to be completed. A

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