Update: Method validation & analytical methods transfer
Implementing current ICH and FDA requirements in practice
- Benefit from our experts’ experience
- Statistical expertise, including a comprehension test
- Avoid common mistakes in the future
- Officially certified: ISO 9001 + 21001
Online-Seminar
From
1.350,00 €
plus VAT
Services & Process
Veranstaltung - 1.350,-€ zzgl. MwSt.
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Period:
from 9:00 am until 6:00 pm CET
You may dial in 30 minutes before the lecture starts
Booking details
Online-Seminar
From
1.350,00 €
plus VAT
Services & Process
Veranstaltung - 1.350,-€ zzgl. MwSt.
The registration fee includes downloadable materials, a certificate, access to the Learning Space, and technical support, including a pre-meeting.
Period:
from 9:00 am until 6:00 pm CET
You may dial in 30 minutes before the lecture starts
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.
Your speakers
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…
Your speaker
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. Additionally, 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…
Your speaker
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…
Your speaker
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.
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 laboratory medicine.
In 2002, he and his…
Your speaker
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 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.
What to Expect
- The regulatory frameworks you need to know
- Acceptance criteria in validation
- Significance and interpretation of deviations
- How to monitor the success of method transfer and avoid common pitfalls
- Statistical expertise for your method validation
Who Should Attend
Are you a laboratory manager looking to exchange views on current challenges in method validation and transfer with industry experts?
Are you an experienced laboratory professional seeking an update on current working practices?
Then this seminar is designed for you!
It is aimed in particular at specialists and managers in the fields of R&D, quality control, and analytics.
Objective of the Event
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, you will be familiar with the regulatory requirements in the EU and the USA, and you will have exchanged insights on acceptance criteria in method validation and analytical transfer. The significance and interpretation of deviations will be illustrated through practical examples. You will also gain awareness of common pitfalls in method transfer.
The statistics lecture clarifies how different types of analytical data are evaluated.
Your Benefit
After completing the seminar,
- you will be familiar with the acceptance criteria for method validation, verification, and method transfer.
- you will have acquired fundamental statistical knowledge for evaluating analytical data (including a short quiz for comprehension review).
- you will be equipped to identify and avoid common mistakes in method transfer.
Programme
from 9:00 am until 6:00 pm CET
09:00
09:15
Dr Ralph Nussbaum
- AMG, AMWHV, IPSE, EU GMP Guidelines
- ICH, WHO Guidelines, USP, EP
- FDA Guidelines
10:15
10:30
Dr Jochen Kirschbaum
- Scope of Validation
- Requirements for key parameters
- Limit of quantification, linearity
- Precision, accuracy, recovery
- Robustness, selectivity
- Documentation: validation plan/report; verification of pharmacopoeia methods
- Requirements during inspections
12:15
13:15
Dr Ralph Nussbaum
- Method validation and transfer
- Characterisation, classification, and risk assessment of deviations
- Significance and interpretation
- Deviation/CAPA management
- Documentation
14:00
Dr Joachim Pum
- How are analytical data evaluated statistically?
- Linearity, precision, and accuracy
15:45
16:00
Dr. Emmanuel Bey
- Selecting a suitable receiving laboratory
- What do both parties need to consider?
- Preparations for the transfer, transfer team
- Transfer plan and transfer report
- Deviations during a transfer
- Parameters for success monitoring (illustrated with examples)
- Common pitfalls
- Frequently asked questions (e.g., Can the transfer be waived?)
17:45
18:00
Welcome, introduction, expectations
09:15
Regulatory framework
Regulatory framework
Dr Ralph Nussbaum
- AMG, AMWHV, IPSE, EU GMP Guidelines
- ICH, WHO Guidelines, USP, EP
- FDA Guidelines
Biobreak
10:30
Acceptance criteria in validation
Acceptance criteria in validation
Dr Jochen Kirschbaum
- Scope of Validation
- Requirements for key parameters
- Limit of quantification, linearity
- Precision, accuracy, recovery
- Robustness, selectivity
- Documentation: validation plan/report; verification of pharmacopoeia methods
- Requirements during inspections
Lunch break
13:15
Deviations
Deviations
Dr Ralph Nussbaum
- Method validation and transfer
- Characterisation, classification, and risk assessment of deviations
- Significance and interpretation
- Deviation/CAPA management
- Documentation
14:00
Statistical aspects of analytical methods validation
Statistical aspects of analytical methods validation
Dr Joachim Pum
- How are analytical data evaluated statistically?
- Linearity, precision, and accuracy
Biobreak
16:00
Setup, acceptance criteria, and success monitoring in analytical method transfer
Setup, acceptance criteria, and success monitoring in analytical method transfer
Dr. Emmanuel Bey
- Selecting a suitable receiving laboratory
- What do both parties need to consider?
- Preparations for the transfer, transfer team
- Transfer plan and transfer report
- Deviations during a transfer
- Parameters for success monitoring (illustrated with examples)
- Common pitfalls
- Frequently asked questions (e.g., Can the transfer be waived?)
Recap and Q&As
End of seminar
Downloads
Request the documents using our form.
Brochure
Whitepaper_Stability-Testing-of-Drug-Products
Weitere Informationen
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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.
Benefits of a FORUM Institut training course
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.
- Live and interactive learning on our Learning Space training platform
- A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
- Easy surveys with Slido
- ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
- A central repository for documents and media
- Other services and apps such as Padlet and Mentimeter available directly on the platform
- The perfect marriage of teaching methods and technology
- High level of interactivity with plenty of opportunity for questions
- Continuous support throughout the event to ensure the most effective learning
- Free technical pre-meeting to start off your training on the right foot
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What satisfied participants say
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Further Information
Your Contact Person
We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de