Das Seminar wendet sich an alle Sachkundige Personen/ QPs. Ebenfalls angesprochen sind Leiter und Mitarbeiter von Qualitätsmanagement und Qualitätssicherung und Mitglieder der Unternehmensleitung, die einen umfassenden Überblick über Pflichten und Aufgaben der sachkundigen Personen/QPs erhalten mochten:
Continue reading “QP Update 2018 – Mannheim, Germany – 19./20. April 2018”
The goal of this GXP guidelines document is to provide life sciences organizations with a comprehensive toolset for using Microsoft Azure while adhering to industry best practices and applicable regulations. It identifies the shared responsibilities between Microsoft and its life sciences customers for meeting regulatory requirements, such as US-FDA 21 CFR Part 11 Electronic Records, Electronic Signatures (21 CFR Part 11), and EudraLex Volume 4 – Annex 11 Computerised Systems (EMA Annex 11).
Venue: Milaneo Office Center, Heilbronner Straße 74, Stuttgart, Germany
The programme will focus on regulated companies that are in the process of the implementation and validation of software development tools like JIRA, BitBucket and Confluence (Atlassian). If such tools are used for GXP activities (GMP, GLP, GDP, GVP, GCP) or medical devices (MedDev) these must comply with regulations like 21 CFR Part 211, Part 820, Part 11 or EMA EudraLex Vol. 4 – Annex 11.
Several standards and guidelines might be applied to the design of the software development lifecycle (SDLC) and the validation of software, like ISPE GAMP, ISO 12207, IEC 62304, CMMI and AAMI TIR45:2012.
This conference covers regulations, standards, examples and solutions!
The event can also be found on XING Event Plus – OPEN LINK.
Continue reading “Events 2018: How to validate Software Development tools used for GXP and MedDev?”
