New AGIT guidelines on computerized systems (GLP)

The Swiss Working Group of Information Technology (AGIT, Arbeitsgruppe Informationstechnologie) consists of representatives of the GLP Compliance Monitoring Units and of invited experts from the industry. Several documents related to information technology in a GLP environment (status of 31.01.2018) have been developed and can be downloaded (source: admin.ch) here:

Download link (external link)

Thanks to the AGIT group for this excellent source of information and sharing it to the public in English language.

PTC Executive Exchange Event: June 28, 2018, Berlin, Germany

Industrie 4.0 – What does this mean for Medical Device and Life Sciences Innovators

Join leaders and industry experts at the 6th PTC Executive Exchange for Medical Device and Life Sciences Innovators. Together, we explore how IoT technology:

  • Increases transparency and advances efficiency to further ensure medical device quality.
  • Impacts the way medical devices are manufactured, operated, and maintained.

Read more….

5. Symposium für Prüfungen in der Medizintechnik- und Pharmaindustrie am 13. Juni 2018 bei Zwick in Ulm

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.

Informationen, Details, Anmeldung (externer Link)

MHRA’s GXP data integrity guide published – March 2018

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”

QP Update 2018 – Mannheim, Germany – 19./20. April 2018

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:

Qualified Person Update 2018 – Neues für die Sachkundige Person in Deutschland;   19./20. April 2018, Mannheim

Zum Online – Programm…

Continue reading “QP Update 2018 – Mannheim, Germany – 19./20. April 2018”