Validation of Analytic Methods (ICH Q2 R2)

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OperationsQuality
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1 day

Program Overview

This course offers a comprehensive exploration of the validation of analytical methods, guided by ICH guidelines. Participants will gain a solid conceptual understanding, practical skills through real-life examples, and strategies to overcome common validation challenges. The program ensures that attendees are well-equipped to apply best practices in their professional roles, enhancing the accuracy and reliability of their analytical methods.

Features

  • Interactive Lectures
  • Industry Expertise: Learn from specialists deeply entrenched in the pharmaceutical industry, providing real-world perspectives and practical insights

Target audiences

  • Professionals in the pharmaceutical industry involved in clinical trial management, regulatory affairs, quality assurance, and drug development.

Instructor

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Dr.Kirit Ladage

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1 Course

I am an accomplished professional delivering over 3 decades of career success in the Pharmaceutical industry, specializing in small molecule research and development.

My dexterity lies in operational governance, process improvement, project management, and analytical development within R&D, contributing to the successful implementation of various interventions and initiatives. Demonstrated excellence in spearheading the QC lab functions, method introduction & set-up, calibrations & routine PM of lab equipment with regular audit (internal and external).

Over the time, I have proved my excellence in wide range of technical areas, including analytical method development and validation, quality control, GMP compliance, regulatory affairs, project management, risk assessment, and process improvement.

Achieved a notable accomplishment in the current role by implementing amongst various processes, the stage gate process for new product development, resulting in a significant reduction in development timelines and increased productivity.

I have mastered the administration of supervising QC work & documentation as per pharmaceutical industry regulations & various other regulatory authorities such as USFDA, TGA, WHO, MCC, MHRA, ANVISA and PMDA

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