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
The US FDA Agency was announcing the availability of a draft guidance for industry entitled ‘‘Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.’’ The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products.
Data integrity has become a major challenge but also a chance for modernization and optimization. To comply with expectations and regulations, companies need to analyze their overall GMP data management, system landscape and related GMP data flows. The following article outlines a basic data-flow oriented approach for such data assessments, as well as considerations for compliant and proper data categorization, how to define different useful types of audit trails and how to define and understand the so called “Audit Trail Review” in order to gain knowledge about the product and process attributes according to ICH Q10 and Q11. (…)
Auszug aus dem GMP-BERATER
Dokumentation ist ein wesentlicher Bestandteil des pharmazeutischen Qualitätssystems. Sie spielt in jeder Phase des Lebenszyklus eines Arzneimittels eine wichtige Rolle, denn die Qualität eines pharmazeutischen Produktes muss zweifelsfrei nachweisbar sein! Deshalb ist es kaum verwunderlich, dass viele Verantwortliche aus dem Pharmabereich mit einer wahren Flut an Daten und Dokumenten kämpfen müssen.
Dieses Fachbuch hilft Ihnen Schritt für Schritt, den Überblick über die Datenflut zu behalten. Neben Erläuterungen zu aktuellen regulatorischen Anforderungen finden Sie hier auch das 1×1 der guten Dokumentationspraxis im täglichen Umgang mit Dokumenten. Das Buch liefert Ihnen Informationen zu unterschiedlichen Systemtypen, GMP-relevanten Funktionen und Einsatzmöglichkeiten elektronischer Systeme. Mit diesem Wissen sind Sie gut vorbereitet für die nächste Datenflut!
Mehr Informationen zum Buch: externer LINK
Please find below the German translation of PIC/S PI 041-1:
GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS
Deutsche Übersetzung (freie Übersetzung) des PIC/S PI 041-1:
Link: Übersetzung PI_041_1_Draft_2_Guidance_on_Data_Integrity
Find more information and download for free at: DOWNLOADS
Partnership Announcement Radbee and CCS
CCS is delighted to announce a strategic partnership with Radbee Ltd. London, UK. RadBee Ltd. offers software solutions for quality assurance in the medtech, biotech and pharmaceutical industries. By tailoring JIRA and Confluence software to meet their clients’ specific needs, RadBee Ltd. creates quality management systems that make compliance easy and help organizations achieve more.
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
Seriously, who will review the Audit Trail Review? First who will execute the Audit Trail Review? An internal Quality role – in the course of the batch by batch execution and review of records, during internal inspections or during an regulatory inspection preparation? Or weekly, bi-monthly or every third batch – or simply just all audit trails created by a system?
And who will analyze in detail and finally judge the results of the Audit Trail Review?
In 2016 a lot of questions were asked about the good old Audit Trail and about the new topic of the so called “Audit Trail Review”. CCS has published a concept paper for an Audit Trail Specification and some considerations for the Audit Trail Review approach.
You may find some answers or at least ideas for that in the free download provided by CCS below:
Download (revision 1): CCS_ Audit Trail Specification and Review_ 2017_rev1
Find more free Downloads at our: Download Page
Link – New Article: Who will review the Audit Trail Review?
Contact us for more information: mailto:talk@comes-services.com
