METHOD VALIDATION

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

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Agenda:

DAY 1:

Session 1: Overview of the guidelines

9.00-10.30 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

10:30 - 11:00 Coffee Break

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