On 30 November 2018 PIC/S revised the current revision of PI 041-1 – DRAFT 3. Here is the announcement from the PIC/S website (source) Focused stakeholders consultation on revised draft PIC/S guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments Geneva, 30 November 2018: a revised Draft PIC/S Guidance on Good …

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Join our Event in London, UK about “Practical Solutions in Computer Systems Validation (CSV) and Software Development” including Jira / Confluence GXP solutions, GAMP validation approaches for SDLC best practice, GXP compliant cloud solutions and much more… Date and Time Wed 3 October 2018, 09:00 – 17:00 BST Add to Calendar Location Royal College of General Practitioners, …

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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 …

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Read here our latest article on LinkedIn about the EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines website and presence. Is our criticism justified and fair? Read it online here. 

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 …

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Behörde und Industrie im Dialog Erfahren Sie bei diesem Seminar wesentliche Zusammenhänge der strategischen Planung und Verwaltung von GMP-Daten. Im Wechsel präsentieren die Referenten aus Behörde und Industrie gesetzliche Anforderungen und Lösungen. Mehr Informationen zum Event – externer Link

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. Read more (external link)

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 …

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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 …

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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 …

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