13 enero, 2021

ISO 14971:2019 Medical devices — Application of risk management to Medical Devices

Contexto En diciembre de 2019 se publicó la tercera edición de la ISO 14971:2019 Medical devices — Application of risk management to medical devices que sustituye […]
13 mayo, 2020

EUGMP Anexo 1: Requerimientos para Productos Estériles

EUGMP Requirements on Sterile products … What’s next?   EUGMP Annex 1 was first published in 1971 and the current version came into operation on 2009 […]
29 abril, 2020

Nitrosamines: Risk Evaluation Required by the European Medicines Agency (EMA)

On September 19th 2019, the European Medicines Agency (EMA) notified all Marketing Authorisation Holders (MAHs) to evaluate the risk of the presence of nitrosamine impurities in […]
15 abril, 2020

Medical Cannabis Products

Although it could look like a simple issue, a difficult thing to decide about the Medical Cannabis is the classification of the product from a pharmaceutical […]
7 abril, 2020

TrackWise Webinar

De la mano de nuestros socios Sparta Systems, desde TDV SL les recomendamos los siguientes webinar, que estamos seguros les aportarán conocimientos valiosos (acceda en el/los […]
6 abril, 2020

Audits in Coronavirus times

Suppliers audits have become throughout the last fifteen years a pillar component of the pharmaceutical quality system. Today’s GxP compliance cannot be understood without a sound, […]
6 abril, 2020

Nueva Guía de la MDCG 2020-1 referida a la Evaluación Clínica de Medical Device Software

El MDCG (Medical Device Coordination Group) es un grupo de expertos registrado por la Comisión Europea y cuyo propósito es el de asistir a ésta y […]
6 abril, 2020

Farmaforum 2019

Nos complace informaros que TDV participará en la sexta edición del congreso Farmaforum los días 28 y 29 de marzo en IFEMA (Madrid). Este evento sirve como punto […]
6 abril, 2020

Data Integrity and Compliance With Drug cGMP: Q&A Guidance for Industry

Just last week, the US FDA published the final version of its Data Integrity and Compliance with cGMP Guidance, which had been issued as a draft in […]