Impurities Training Course - US edition

LEARNING OUTCOMES

This comprehensive masterclass series provides an in-depth understanding of impurities in pharmaceutical products, covering regulatory guidelines, risk assessment, structure elucidation, method development, and validation. Participants will gain practical knowledge through case studies, workshops, and interactive discussions, enabling them to manage impurities with confidence.

YOU WILL LEARN ABOUT

-Understand Global Regulatory Frameworks:
Gain a solid grasp of ICH Q3A-D, M7, Q14, Q2(R2), and their application in impurity management.

-Perform Risk-Based Impurity Assessments:
Learn how to set up risk assessments for different impurity classes, including mutagenic and elemental impurities.

-Master Analytical Techniques for Impurity Determination:
Explore advanced methods such as LC-MS, GC-MS, ICP-MS, and spectroscopic approaches, along with a brief overview of bioanalytical techniques.

-Develop and Validate Analytical Methods:
Understand method requirements, validation parameters, and practical challenges in compliance with ICH guidelines.

-Establish and Qualify Reference Standards: 
Gain hands-on knowledge on sourcing, qualification, and handling of impurity standards, ensuring readiness for regulatory inspections and audits.

-Apply Knowledge Through Case Studies:
Work on real-life scenarios to translate theory into practice for impurity determination.

-Build a Compliance-Driven Mindset:
Learn how to integrate impurity management into a robust quality culture across pharmaceutical operations

 

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4 Modules, 12 Days, 4 Key Topics