Expert training for healthcare, with emphasis on the diagnostic laboratory.
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 …
LDT Phase VII: Development of a Quality Management System Read More »
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 …
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 …
Crosswalk between the 12 Quality System Essentials/ 21 CFR 820 and compliance to design control. LDT Phase VII QMS Development from Laboratory Learning Solutions on Vimeo. The intent of a pre-assessment or a cross walk is to review the list of management principles in each standard to gain a deep understanding of the meaning of …
LDT Phase III: Pre-Assessment of Existing Processes Read More »
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 …
Expert online non-technical training courses for continuing education or to learn a new skill right at your fingertips.
