Implementing current ICH and FDA requirements in practice
Webcode 26112464
Dr. Emmanuel Bey
Pharmaceutical consultant and expert in analytical chemistry
Prior to joining A&O Pharma GmbH in September 2023, he has worked for 9 years at Develco Pharma GmbH, a pharmaceutical company specialised in the development and manufacturing of delayed release formulations. His work focuses on development and validation of analytical methods, the quality control of incoming goods as well as the manufactured products. Additionaly, he had the lead of the QC team (up to 25 laboratory technicians), responsible for the personal GMP training, the writing of IMPDs, dossiers and resolving compliance issues. As head of QC, he was also directly involved in the trouble shooting of product manufacturing related issues. Core competencies: Chemist by education, PhD in pharmaceutical chemistry, Development and validation of analytical methods, Quality control, Professional development in pharmaceutical technology, pharmaceutical biology and pharmacology (four semester at the university of Tübingen, Germany), Qualified Person according to §15 AMG, Responsible person Narcotics
Dr. Jochen Kirschbaum
SGS Analytics Germany GmbH, Aachen, GERMANY
Scientific Director Jochen Kirschbaum is a chemist who earned his Ph.D. in food chemistry. After working at the Institute of Nutritional Sciences at Justus Liebig University in Giessen, he joined Analytical Services (now SGS Analytics Germany GmbH) as a laboratory manager in 2007. There, he served as laboratory manager, head of quality control, and scientific director. Through these roles, he has been a GMP expert for many years, specializing in the areas of validation and routine analysis.
Dr. Ralph Nussbaum
betapharm Arzneimittel GmbH, Augsburg, GERMANY
Qualified Person
Dr Nussbaum has been Qualified Person at betapharm Pharmaceuticals since March 2026.
Over the past 30 years, he has held senior QC/QA positions at various pharmaceutical companies, including Omega Pharma, AuregenBiotherapeutics, Synlab, Analytical Services, Carbogen-Amcis, and Grünenthal.
His areas of expertise include analytical method development, method validation and transfer, and equipment qualification.
Dr Nussbaum has been a speaker in these fields for many years.
More information please click here.
Dr. Joachim Pum
ApherMED Zentrum für moderne Diagnostik und Therapie, Jena, GERMANY
Owner
After studying medicine in Pretoria/
South Africa, Joachim Pum decided to specialise in
specialising in laboratory medicine.
In 2002, he and his family moved to Europe, where he worked as a laboratory doctor for Medical Research
Laboratories International (later PPD Global
Central Labs), a study laboratory in Brussels.
As a nationally and internationally recognised
laboratory specialist, he held several
leading positions in medical laboratories. From
2013 until 2024, he held the position of medical
director.
He founded Firma ApherMED - Zentrum für moderne Diagnostik und Therapie in September 2024. ApherMED is specialised in therapeutic Apherese, laser treatment and infusion therapy.
More information please click here.
18/11/2026
18/11/2026
from 9:00 am until 6:00 pm CET
You may dial in 30 minutes before the lecture starts
online
online
Event - 1,350€ plus tax
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Event - 1,350€ plus tax
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de
Master GMP-compliant method validation and analytical method transfer in one focused online seminar. Walk away with practical knowledge of current ICH and FDA requirements, solid statistical foundations, and the confidence to avoid common pitfalls in method transfer.
This seminar provides a platform for discussing current challenges in method validation and analytical method transfer with industry experts.
The focus is on chemical substances. Methods for substances of biochemical or microbiological origin are not covered.
After completing the seminar,
09:00 Welcome, introduction, expectations
09:15
Dr Ralph Nussbaum
10:15 Biobreak
10:30
Dr Jochen Kirschbaum
12:15 Lunch break
13:15
Dr Ralph Nussbaum
14:00
Dr Joachim Pum
15:45 Biobreak
16:00
Dr. Emmanuel Bey
17:45 Recap and Q&As
18:00 Ende of seminar
Are you looking for this training for multiple employees?
We offer the right solution, either on-site or in a virtual format!
We also offer this seminar as an in-house seminar.
Take advantage of the proven concepts from our open seminars and bring your employees
up to the same level of knowledge quickly and easily.
We would be happy to send you a no-obligation offer.
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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Teilnehmerstimmen Juli 2018
Sehr informativ, interessant und hilfreich aber auch sehr theoretisch.
Anne-Katrin Lichtenberg
Ciech Soda Deutschland GmbH & Co.KG
Informativ, in bestimmten Sachen hilfreich.
Jacqueline Wenzel
Ciech Soda Deutschland GmbH & Co.KG
Guter Überblick über die momentanen Anforderungen bei Validierungen und welche Aspekte bei einem Transfer beachtet werden sollten.
Kurzer, knapper und informativer Gesamtüberblick.
Jana Vogt
Celonic Deutschland GmbH & Co. KG
