- Online training -
Webcode 24092481
Dr. Cornelia Hunke
DiQualis - QA, Quality Manager, Quality Auditor and former federal GLP Inspector
In the past, she held - among other things - the position of deputy head from 2015 to 2020 and until 2022 the comm. Head of the German GLP Federal Office at the Federal Institute for Risk Assessment (BfR) and was technically responsible for the accredited laboratories of the BfR including the NRLs located there. She has extensive experience from industry, the public sector, research, universities and institutions in Germany and abroad (Germany, Singapore, China). Since August 2022, Dr Hunke has been working as a consultant at DiQualis Germany with expertise in ISO and regulatory GxP requirements as well as laboratory-related computerised systems (LIMS, eSignature, ELN, eDMS).
More information please click here.
Dr. Timo Kretzschmar
ext. Consultant for INOSOLVE Consulting Service & Engineering GesmbH, Vienna
Dr Timo Kretzschmar was head of Q at a pharmaceutical analytical CRO from 2003 to 2016, from 2016-19 as inspector for GLP and computer-aided systems under GxP at AGES/BASG. From 2019-21 he was Sen. Consultant at anapur AG Vienna Region and in 2021 Q-Head GMP at Biomedical Research & Bio Products AG Vienna. From December 2021 to January 2023 he was Sen. Consultant/Project Manager for GxP/CSV (Consulting, Trainings, Audits) at Inosolve Consulting Service & Engineering GesmbH, for which he has been working as an external consultant since February 2023. Since February 2023, he has been working full-time for SCS-TECHNOLOGY Verfahrenstechnik GmbH, Linz. Dr Kretzschmar has been a part-time external lecturer at the FH Campus Wien since around 2007.
More information please click here.
Dr. Ronald Schmidt
Sanofi-Aventis Deutschland GmbH, Frankfurt
Head of Quality Assurance GLP After studying pharmacy, obtaining his licence to practise medicine and completing his doctorate, Ronald Schmidt joined Sanofi-Aventis Deutschland GmbH in 2006 as Principal Investigator for bioanalytical phases of GLP and GcLP studies (validation of various software products and development of new electronic workflows). In addition, he writes his own software, which is used in the regulated area of Sanofi-Aventis Deutschland GmbH. In 2015, R. Schmidt moved to Quality Assurance and has been Head of GLP Quality Assurance since 2017. Since 2019, he has headed the IT working group of the GQMA (German Quality Management Association).
24/09/2024
24/09/2024
09:00 am - 05:00 pm - online training
You may dial in 30 minutes before the training starts
online
online
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
Get practical expertise for the GMP, GLP and GCP-compliant archiving of relevant documents and the efficient integration of the archiving system into your daily work processes. The three experts will show you some practical approaches to typical pitfalls.
Archiving relevant documents in a GxP-compliant manner is anything but trivial. Carelessness and errors can quickly lead to complaints, deviations or official warning letters.
Today, there are more detailed IT-regulations due to greater digitisation and more and better trained inspectors.
This applies to digital archiving and corresponding cloud-based systems too.
The aim of the online seminar is to provide practical know-how for the GMP-, GLP- and GCP-compliant archiving of your documents as well as the effective and efficient integration of the archiving system into your daily work processes.
Among other things, the experts will address the aspects of audit security, electronic archiving, outsourcing and common deficiencies during audits and inspections.
You will apply the theoretical knowledge you have learnt directly in the practical workshop using realistic example scenarios.
Use this online seminar as a practical guide to minimise sources of error in future and to be optimally prepared for inspections by the authorities!
What can you expect and what will you take away?
Here is an excerpt of the feedback from last year's participants:
09:00 Welcome, introduction, expectations
09:15
Dr Timo Kretzschmar
10:00
Dr Cornelia Hunke and Dr Timo Kretzschmar
11:00 Bio break
11:15
Dr Ronald Schmidt
12:30 Lunch break
13:30
Dr Timo Kretzschmar
14:30 Bio break
14:45
Dr Timo Kretzschmar
15:45
Dr Cornelia Hunke
16:45 Audits and inspection of archiving systems
17:00 End of the seminar
This seminar can be taken as elective module as part of our qualification program to become an IT-Quality-Specialist.
The course concept:
FORUM Institut’s all-in-one training platform uses the latest teaching methods.
All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.
You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.
The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.
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