Investigación de Fallas de Laboratorio by Biobusiness Research

Investigación de Fallas de Laboratorio

Cómo Investigar Resultados No Esperados 
Fuera de Límite (OOL) / Fuera de Especificación (OOS)

Descripción

Los laboratorios regulados que se rigen por un sistema de calidad, al realizar una prueba y obtener un resultado fuera de especificación, no esperado o sospechoso, tienen que investigar para determinar la causa de la falla. Estas investigaciones tienen que realizarse a tiempo, estar bien documentadas y con base científica. La FDA y otras agencias reguladoras se enfocan en estas investigaciones de laboratorio. Las investigaciones de fallas, de fuera de límite o fuera de especificación son criticas en los laboratorios de control de calidad.

En este curso online se discutirá lo fundamental que debes conocer acerca de las investigaciones de laboratorio.

Es un curso introductorio, diseñado para estudiantes, recién graduados y los interesados en los Laboratorios de Calidad en las industrias biomédicas (ejemplo: farmacéutica, dispositivos médicos, biotecnología).


Temas:

 

  • Laboratorios de Calidad (QC)

  • Términos asociados a investigaciones: OOT / OOL / OOS

  • Regulaciones y Guías (cGMP/cGLP/QSR/FDA Guidance)

  • Resultados Fuera de Especificación / Fuera de Limites / Desviaciones / No Conformidades

  • Realizando la Investigación

  • Identificación del Resultado No Esperado

  • Plan de Investigación

  • Componentes del Reporte de Investigación

  • Análisis de Data

  • Determinar Causa Raíz

  • Establecer Acciones Correctivas y Preventivas (CAPA)

  • Documentación de la Investigación

  • Observaciones Regulatorias / Ejemplos de No cumplimiento

El curso consiste de una combinación de videos lecciones de la presentación (voice over presentation), la presentación en formato PDF, audio, y material de referencia. 


* Toda venta es final.  No se hace devolución de dinero.  No refund. *

Código de Curso: BRI-LAB-1909-B


Contenido

Bienvenidos al Curso
¡Bienvenidos al Curso!
Introducción
I. Introducción al Curso
1.1 - Introducción al Curso
14 mins
1.2 - Introducción a las Investigaciones de Fallas
9 mins
1.3 - El Laboratorio de Calidad
4 mins
1.4 - Introducción a la Industria Biomédica
11 mins
1.5 - Desviaciones
10 mins
1.6 - Investigando Resultados Fuera de Especificación (OOS)
14 mins
1.7 - Referencia: Guia de FDA de Investigaciones de OOS
85.6 KB
1.8 - Investigaciones en el Laboratorio (Presentacion PDF)
3.29 MB
II - Investigando Resultados Fuera de Especificación
2.1 - Introducción al Módulo
2.2 - Fases de la Investigación
35 mins
2.3 - Fases de la Investigación (Presentación PDF)
1.08 MB
2.4 - Principios de Investigación
9 mins
2.5 - Principios de la Investigación (Presentación PDF)
702 KB
2.6 - Reporte de Investigación
5 mins
¡Bienvenidos al Módulo # 3!
¡Bienvenidos al Módulo # 3!
Prueba Corta - Verificación de Conocimiento
Reporte de Investigación (Presentación PDF)
1.06 MB
Resumen: Investigación de los resultados de las pruebas fuera de especificación (OOS)
Definiciones
Procedimiento de Investigaciones
Checklist de Investigación
Ejemplo de Checklist de Investigación.pdf
231 KB
Tarea de Evaluar Conocimiento:
Tarea de Evaluar Conocimiento
Respuesta a Prueba Corta - Verificación de Conocimiento
Conclusión del Curso
Conclusión del Curso:

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No Refund Policy

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About Biobusiness Research

At Biobusiness Research, we want to provide the basic tools and knowledge on various topics related to the biomedical industry. We promote a series of conferences, workshops, lectures and seminars (face-to-face and / or online), in an accessible way. We recognize that many times acquiring advanced technical knowledge in areas of science and technology is not so accessible to the general community, and that is why the Biobusiness Research initiative arises: promoting knowledge in an accessible way.

In Biobusiness Research we have the collaboration of staff with academic and industry experience. Our facilitators have experience in both industry and academia, so that they can understand current practices that add value in the labor market and transmit knowledge to the community in general.

Biobusiness Research is not an academic institution.  It is a C -corporation established in the state of Florida (Biobusiness Research, Inc), Puerto Rico (Trecon, Inc.), and New York (Biobusiness Research, Corp).  Biobusiness Research goal is to promote knowledge.  We develop specialized, skill-based courses facilitated by industry and academy experts.  

Biobusinessresearch.net is an online platform that allows to obtain specialized training, knowledge and skills in an accessible and cost-effective way.  Our goal is to develop specialized training at a reasonable price so most of the people can have the possibility to access them.

Our programs target those individuals and students that wants to learn and get access to specialized training and knowledge but has some challenges to afford the expensive price for this type of training of most organizations.  Also, we want to target those who just want to learn at their own time and convenience, anytime, in an easy, flexible and accessible format.

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