Method Development, Validation and Transfer with focus on ICH Q2(R2) and ICH Q14 MasterClass - EU edition

02-03 February, 2027

Analytical Life Cycle Management

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

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Key learnings

Introduction

Introduction of ICH Q2(R2): what has changed?

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.

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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

Trainer

Dr. Ralph Nussbaum

Head of Quality & Qualified Person
Omega Manufacturing GMBH & CO KG
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.

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Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

Gain value and learn from the best instructors

Networking

Build a top-notch community and advance your career

Who should attend img 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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Testimonial

Our success stories

"The quality of the presentations, the relevance of the topics, and the overall level of discussion were outstanding and highly valuable from a professional and practical perspective. The event provided meaningful insights and a very good platform for knowledge exchange"

Ana Narasanova

Manager Credit Risk
NLB Banka
North Macedonia

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

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