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”
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?”
The Conference is designed for all Qualified Persons and aspiring Qualified Persons. It also addresses upper management functions and authority representatives who want to be informed about the latest development regarding the duties and responsibilities of Qualified Persons.
29. and 30. September 2017
Venue Best Western Hotel M 56a Bulevar Oslobođenja Street, Belgrade
Read more: http://www.pharmacy.bg.ac.rs/files/Doga%C4%91aji/2017/QP%20konferencija/flajer%20engleski%202017.pdf
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.
Get practical knowledge of:
ECA Training: Hamburg, Germany
Die Datenintegrität der GMP-Daten ist ein zentrales Inspektionsthema. In diversen US FDA Warning Lettern als auch EMA GMP Reports werden bereits entsprechende Mängel dargestellt. Im Seminar lernen Sie die Anforderungen an die Datenintegrität kennen und Sie erfahren die aktuellen Richtlinien und Inspektionsergebnisse.
PTS Schulung am 13.-14.06.2017 in Baden-Baden:
Link für mehr Infos und zur Anmeldung…
Inhalte sehr detailliert und praxisnah; gute Darbietung; lebhafte Diskussion Gute Atmosphäre; aktive Mitarbeit; Zahlreiche Workshops und praktische Beispiele waren super!
Kontakt: talk@comes-services.com
Bedeutung des Data Governance Systems für die Pharmawelt:
This Conference is designed by QPs for QPs as an international Expert Forum with focus on sharing information and experience and on discussing the critical areas of the QP’s daily work.
Continue reading “QP Forum 2016 – Madrid, Spain 1 – 2 December 2016”
Come and visit us the ILMAC Messe Basel to the Data Integrity session on 20. September 2016, 09:30 – 12:40.
Read more: External Reference
comes compliance services (CCS), a leading GXP consulting service provider, for Pharmaceutical Quality Systems, Data Governance and Integrity, Computer System Validation and Inspection Readiness Programs, today announced that it has acquired more than 100 business customers since the launch of its services in 2009. Pharmaceutical and Medical Device customers rely on the compliance and consultancy services since many years provided by CCS. About 80 % of CCS projects are repeat-business and sales continue to ramp steadily. Continue reading “CCS – 100 – business customers reached in 2016”
The European Medicines Agency (EMA) has added to the GMP Q&A blog the topic “Data Integrity”. The agency states that the questions should be read in conjunction with Eudralex Volume 4 (GMP guidelines). Find all 23 of the questions and answers via the following link.
