Stability Testing for Drug Substances and Drug Products for US

Stability Testing for Drug Substances
and Drug Products for US

Days

Hours

Minutes

Seconds

This course includes:

Collaborative environment that
encourages interaction
Case studies and Q&A sessions
Training materials
Tools and techniques to apply
immediately in your role
Recording access
Certificate of completion

Course outline

What makes stability testing so pivotal? It’s the foundation of ensuring that drug substances and products maintain their integrity over time, under various conditions. This masterclass dives deep into the science of degradation, regulatory guidelines, and advanced strategies like bracketing, matrixing, and predictive modeling. Imagine confidently implementing stability studies that meet global standards while optimizing efficiency and cost.

What You’ll Gain

Comprehensive Stability Knowledge
Grasp essential principles and global regulatory frameworks, including ICH Q1 and Q2.
Innovative Testing Techniques
Master approaches like bracketing, matrixing, and extrapolation to streamline processes without compromising results.
Practical Skills
Use simulations, case studies, and hands-on tools to apply stability concepts in real-world scenarios.
Regulatory Readiness
Stay ahead of evolving standards and ensure compliance with cutting-edge validation methods.

Why This Masterclass?

Learn from an Authority
Dr. Joachim Ermer brings decades of industry expertise, providing unparalleled insights into stability testing and regulatory compliance.
Comprehensive Content
Access in-depth training enriched with practical tools like Excel worksheets for direct application.
Interactive Learning
Engage with discussions, Q&A sessions, and simulations to gain actionable, hands-on knowledge.

Who Should Attend?

Agenda Highlights

Day 1

Day 2

Day 3

About Trainer

Following study of biochemistry and PhD thesis in enzyme kinetics, Dr. Ermer started
his career in pharmaceutical analytics and industrial Quality Control in 1991. He held
various positions, including head of laboratory within the analytical drug development at Hoechst AG, Frankfurt, Germany, and from 2001 to 2005 a global function as Director of Analytical Processes and Technology. This included consultation, harmonisation, trouble-shooting and training of all industrial sites of Aventis with respect to Quality Control topics. From 2005 to 2010, he served as head of Quality Control Frankfurt Chemistry, Sanofi, Germany. Between 2010 and 2018, Dr. Ermer was head of QC Services which included a reference standard group with the mission to provide company-wide management and distribution of analytical reference standards. From 2018 to 2020, he held the responsibility as head of QC Lifecycle Management Frankfurt Chemistry, and evaluated compendial and regulatory changes, supported and coordinated analytical transfers, validation and implementation projects, in particular the establishment of a quality system and routine monitoring programme for continuous performance verification of all API-methods.

Dr. Ermer is member of the USP Expert Committee “Measurement and Data
Quality“, the Ph.Eur. Working Group “Chromatographic Separation Techniques”, and
Advisory Board member of the ECA Analytical Quality Control Group. He authored
more than 60 publications on analytical topics and is editor and author of the two
editions of the book “Method Validation in Pharmaceutical Analysis. A Guide to Best
Practice” (Wiley-VCH, 2005 and 2015).