You will understand the purpose and organisation of regulatory inspections and you will learn how to prepare your company to pass an inspection or customer audit and how to assure the most positive outcome.
Die Medizintechnik- und Pharmaindustrie stellt höchste Ansprüche an die Sicherheit für Patienten und Anwender, bei der Prüfungsdurchführung und bei nachvollziehbaren und geschützten Daten. Zudem muss die Produktsicherheit während der Entwicklung, Produktion und Qualitätskontrolle stets im Fokus stehen und durch geeignete Prüftechniken nachgewiesen werden.
Das Zwick Roell Symposium am 13. Juni 2018 bei Zwick in Ulm nimmt diese Themen auf und bietet Ihnen Einblicke in aktuelle Prüfaufgaben aus Industrie und Forschung.
After the British agency MHRA has published three (3) different draft versions of the – MHRA GMP Data Integrity Definitions and Guidance for Industry – in January and March 2015 (GMP) and in July 2016 (Draft for consultation – now for GXP) the final “Medicines & Healthcare products Regulatory Agency (MHRA) ‘GXP’ Data Integrity Guidance and Definitions was published in March 2018.
Looking into the history of the document and content the major changes have been to replace and extend from “GMP” to GXP (covering GCP, GDP, GLP, GMP and GPvP). All this GXP areas had already requirements for data integrity or study integrity or similar for many years and are covered by European EMA regulations, directives and the EMA EudraLex Volumes or other regulations (e.g. chemical for GLP). The second change was the title “Guidance for Industry” to a “Guide“. Maybe the document type “Guidance for Industry” would remind you to US regulations and you are right. But in the EU such a document type in a regulatory structure and understanding is also not known. Maybe the roots of the first versions were coming from US or consultants or authors from this region. In general an own opinion might be better as to listen to any opinion-makers with commercial interests. Continue reading “MHRA’s GXP data integrity guide published – March 2018”
After our successful event on 8. February 2018 we have planned to repeat it on the 27. November 2018 in the city of Stuttgart, Germany. Based on the input and feedback from the initial event we have improved several sessions and added a guest speaker.
Read more: Registration and Information page
If you have any questions please contact us at: firstname.lastname@example.org
LOGFILE Nr. 02/2018 – Regulatorische Anforderungen an ein elektronisches Chargendokumentations- und Freigabesystem
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:
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).
8 February 2018, Stuttgart, Germany (9 am to 5 pm)
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.
1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection outcomes and hence for better use of inspection expertise and resources.
Read our new article on LinkedIn: Software Development
Validation of SDLC tools like Confluence, JIRA according ISPE GAMP 5.