CMC Statistics
14 – 16 October 2025
1 850 €
TRAINING TIMES
13:30 - 18:00 Vienna
12:30 - 17:00 London
07:30 - 12:00 New York
04:30 - 09:00 Los Angeles
WHY SHOULD YOU ATTEND?
Understand the value of statistics in CMC
Learn how ICH guidelines and regulatory agencies expect statistical methods — and how they help ensure safe, effective products that meet patient needs.
Apply statistics beyond compliance
See how statistical thinking improves product and process understanding, reduces risk, and drives better decisions.
Build a robust, risk-based control strategy
Use data to define specifications, optimize processes, and meet validation and stability requirements with confidence.
Connect science with regulatory expectations
Align process knowledge, statistical evidence, and patient-focused specifications to accelerate approvals and avoid rejections.
OUR ONLINE TRAINING EXERIENCE INCLUDE
Two half-days of expert-led Zoom sessions packed with case discussions, Q&As, and real-world scenarios
All slides, tools, and supporting materials available in one place – before, during, and after the course.
Receive a digital certificate (also LinkedIn-ready) that verifies your skills in strategic trial planning.
LEARNING OBJECTIVES
Design trials that fit the setting
Use statistics to define sampling and acceptance criteria, even when standard models don’t apply.
Pick the right endpoints and acceptance criteria
Learn to justify limits and decisions using DoE, control charts, and statistical intervals.
Leverage the data you already have
Use trends, real-world evidence, and stability data to make better regulatory and business decisions.
Build a defensible process control strategy
Turn risk analysis and process performance data into a sound ongoing verification plan.
Navigate complex CMC risks
Identify patient, product, and process risks and apply data-driven tools to manage them effectively.
WHO IS THIS TRAINING FOR?
Process Validation
Process Development
MSAT
Process Improvement
Quality Assurance
Data Scientist
CMC Statistician
Technology Transfer
KEY TOPICS
Apply statistical methods across the CMC lifecycle
Design experiments to optimize processes
Sample and set acceptance criteria with confidence
Monitor stability trends and define shelf life
Visualize data to support decisions
TRAINER
PAST PARTICIPANTS
CMC Statistics
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
