Introduction
Introduction of ICH Q2(R2): what has changed?
pharma
Method Development, Validation and Transfer with focus on ICH Q2(R2) and ICH Q14 MasterClass - EU edition
02-03 February, 2027
02-03 February, 2027Virtual
This Online Masterclass gives practical examples of Method Validation and Method Transfer and also lets participants ask questions interactively throughout the session.
02-03 February, 2027, Virtual
Time Zone: UTC/GMT+1/CET
Key learnings
ICH Q14
ICH Q14 and its link to method validation.
Significance
The significance of the ATP (Analytical Target Profile).
Practical Example
Practical examples for method validation and method transfer.
Acceptance Criteria
Acceptance criteria for method validation.
Regulatory Validation
Regulatory validation and transfer requirements for US and EU.
Trusted by over 17,000 delegates across leading companies
Overview
The new final ICH guideline for method validation ICHQ2(R2) was put into effect in June 2024. Together with the new ICHQ14 guideline for method development, both guidelines represent a fundamental change of direction in method development and validation, e.g. implementation of ATP (analytical target profile) and analytical lifecycle management.
The WHO guidelines on transfer of technology in pharmaceutical manufacturing as well as the new draft ICH guidelines represent the new basis for the transfer of analytical methods.
#masterclass #glceurope #pharmaonlinetraining #globalleadingconferences #methodvalidation #methodtransfer
Meet the expert
Trainer
Dr. Ralph Nussbaum
Head of Quality & Qualified Person<br/>Omega Manufacturing GMBH & CO KG<br/>Germany
Dr. Ralph Nussbaum is Head of Quality and Qualified Person at Omega Pharma Manufacturing in Germany. He has extensive experience in pharmaceutical quality management and leadership. Since 2020, Dr. Nussbaum has served as Vice President of
Quality Management and Managing Director, Member of the Board at Auregen BioTherapeutics GmbH in Reutlingen. Prior to that, from 2017 to 2020, he was Market Segment Leader Pharma and Site Manager at SYNLAB Analytics & Services Germany
GmbH in Aachen.
A chemist by training, Dr. Nussbaum began his career in quality control at Grünenthal GmbH and later worked as Manager of Quality Assurance at CarboGen Laboratories AG. From 2003 to 2017, he held the role of Managing Director of Analytical Services, further broadening his expertise in analytical and quality operations within the pharmaceutical industry.
Quality Management and Managing Director, Member of the Board at Auregen BioTherapeutics GmbH in Reutlingen. Prior to that, from 2017 to 2020, he was Market Segment Leader Pharma and Site Manager at SYNLAB Analytics & Services Germany
GmbH in Aachen.
A chemist by training, Dr. Nussbaum began his career in quality control at Grünenthal GmbH and later worked as Manager of Quality Assurance at CarboGen Laboratories AG. From 2003 to 2017, he held the role of Managing Director of Analytical Services, further broadening his expertise in analytical and quality operations within the pharmaceutical industry.
Reasons to attend a masterclass
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Interactivity
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WHO SHOULD ATTEND
-Quality Control Employees
-R&D Specialists
-R&D Managers
-Quality Control Specialists
-Quality Control Managers
-Analytical Chemistry Specialists
-Analytical Chemistry Managers
-CMC Specialists
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