METHOD VALIDATION

Update on ICHQ14 and ICHQ2 - Analytical LifeCycle Management, Validation and Transfer of Analytical Methods

Master ADC Manufacturing Compliance with Wisdom's Expert Training

Training Schedule (10 & 11 June, 2024)

(10th June, 2024)
14:00 - 18:30 PM UK time


(11th June, 2024)
14:00 - 18:30 PM UK time

Online

Join visionary speakers from leading organisations for crucial insights and expert opinions.

Dr. Ralp Nussbaum,

Dr. Nussbaum worked at Gruenenthal GmbH from 1995 to 2000 as Head of Laboratory R&D Analytics before moving to CarboGen Laboratories AG in Hunzenschwil, Switzerland, as Head of Quality Control and later as the person responsible for drug substances. From the end of 2003 to July 2017, he was Head of Analytical Services in Aachen, now SYNLAB Analytics & Services Germany GmbH. From October 2017, he was responsible for the entire pharmaceutical division of SYNLAB as Division Manager. Since August 2020 he was Vice President Quality Management at Auregen BioTherapeutics GmbH.

Training Schedule (10 & 11 June, 2024)

14:00 - 18:30 PM UK time

Introduction:

The new ICH guidelines Q14 and Q2(R2) give a new new on analytical life cycle management and analytical method validation. With the introduction of the Analytical Target Profile (ATP), the requirements for method validation and method transfer have changed. The new validation guideline ICH Q2(R2) is now additionally oriented towards new methods such as spectroscopy, bioassays and coupled techniques.    

METHODOLOGY

The training program will utilize a combination of lectures, case studies, workshops, and interactive discussions to facilitate active learning and engagement. Participants will have opportunities to apply theoretical knowledge to practical challenges through problem-solving exercises and collaborative activities. The course will be delivered by an expert for method development and method validation.

KEY OUTCOMES

Upon completion of the course, participants will:

  • Gain a comprehensive understanding of best industry practices for method validation and method transfer
  • Receive an overview of the state of the art in life cycle management for analytical methods
  • Learn about practical aspects of method validation and -transfer

Who Should Attend?

This training program is essential for professionals involved in pharmaceutical quality control, including:

  • Analytical Methods Development and Validation Specialists
  • Quality Assurance/Quality Control Specialists
  • Regulatory Affairs Professionals
  • Project Managers

Agenda:

DAY 1:

Session 1: Overview of the guidelines

14.00-15.30 Title: Impact of ICH Q14 and ICH Q2(R2) on method development and -validation

Summary:

  • Overview of of the new guidelines
  • The ATP concept and method validation

15:30 - 16:00 Coffee Break

Join visionary speakers from leading organisations for crucial insights and expert opinions.

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