Meet QFINITY at the 35th GAMP DACH Forum in Frankfurt am Main
03 September 2019 - 04 September 2019
This event will feature three expert presentations on topics proposed by the 34th GAMP D-A-CH Forum participants. In addition, reports on CSV inspections and the work of the active Special Interest Groups and working groups will be presented. Participation is free of charge (except for travel and dining expenses), but requires a separate registration as an active member of GAMP-D-A-CH. Mr. Oliver Herrmann - QFINITY CEO - will present the results of the last GAMP EU Steering Committee meeting.
THE SQUAIRE at airport
60549 Frankfurt (Main- line station area)
QFINITY leads "Introductory seminar validation of computerized systems for beginners"
23 September 2019
Compact introductory seminar for CSV beginners, presenting the basics of the validation of IT systems. Contents: Fundamentals - Legal framework - SOP standards in GxP environments - Basic definitions and key principles – Guidance and interpretive aids - Approaches and methods - The risk-based approach - V-model and alternative process models - Classification of systems and how to assign classes - Life cycle model - Integration of suppliers - Validation of computerized systems in a nutshell - Organization, roles, responsibilities - Requirements and project management – From commissioning to retirement and decommissioning.
Hilton Hotel Mainz
Rheinstr. 68, 55116 Mainz
QFINITY speakers at the seminar "Validation of computerized systems in GxP environments"
24 September 2019 - 25 September 2019
This seminar gives you a compact overview of what is most important in the validation of IT systems in GMP, GCP, GLP or GDP regulated environments. Topics include: What regulations and guidelines you should know – How to plan a VMP correctly, how to prioritize and distribute responsibilities - Documentation, document management & quality control - What matters most in audits and inspections - Analyzing, evaluating and minimizing risks, also with respect to service provider and supplier change management – Preserving the validated status successfully
Mercure Hotel Kaiserhof Frankfurt City Centre
Kaiserstraße 62-64 60329 Frankfurt
QFINITY represented with contribution at the GAMP COP UK Forum
09 October 2019
QFINITY CEO Oliver Herrmann presents a case study on the activities developed by companies to deal with poor outcomes from CSV supplier audits.
Education Session at this year's ISPE Annual Meeting
27 November 2019 - 30 November 2019
QFINITY leads the eClinical Systems Education Session
Caesars Palace Las Vegas
3570 S Las Vegas Blvd Las Vegas, NV 89109 USA
QFINITY represented with speaker at seminar "Data Integrity and Audit Trail Review in Manufacturing"
10 December 2019
Data integrity and audit trail review are inevitably linked to drug production and present companies with a range of challenges. This seminar will help you to master these challenges. You will gain an overview of the regulatory requirements for data integrity and the top findings of authority inspections.
Novotel Munich City Arnulfpark
Arnulfstr. 57 - 80636 Munich
QFINITY represented with speakers at the first 2020 seminar "Data Integrity in GMP".
20 January 2020 - 24 January 2020
A good overview of the current dynamic regulatory landscape and the practical handling of how to establish and maintain data integrity as an integral part of your QM system is of crutial importance. Take the opportunity to be informed by 6 experienced speakers on the subject of data integrity in the GMP area - from regulatory to practical implementation to data protection.
QFINITY represented with speakers at the second 2020 seminar "Data Integrity in GMP"
01 July 2020 - 03 July 2019
Data integrity in the GMP area meanwhile plays an essential role. The seamless integration into quality management, a good overview of regulatory requirements and practical handling are essential. Take the opportunity to be informed by 6 experienced speakers on the subject of data integrity in the GMP area - from regulatory to practical implementation to data protection.