Archive

14 Oct 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...

14 Oct 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...

14 Oct 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...

14 Oct LDT Phase III: Pre-Assessment of Existing Processes

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...

14 Oct Phase 1- II: Leadership & Training

14 Oct 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...