Statistics for Quality Control & Quality Assurance Practice 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

Statistics may seem intimidating, but they don’t have to be. This masterclass breaks down complex concepts into practical, actionable insights. From understanding data distributions to optimizing calibration models, you’ll gain the skills needed to enhance your quality assurance practices. Each session is designed to align with global regulatory standards, ensuring your processes meet industry expectations.

What You’ll Gain

Clarity and Confidence
Simplify statistical fundamentals like variability and calibration and use them to achieve consistent results.
Compliance Know-How
Align your processes with ICH Q2(R2), Q14, and USP <1220> standards.
Real-World Skills
Get hands-on with Excel-based simulations to manage outliers, analyze trends, and improve performance.
Improved Decision-Making
Learn how to interpret and apply data insights effectively in your role.

Why This Masterclass?

Learn from the Best
Dr. Joachim Ermer’s extensive experience ensures you’re getting the most reliable, up-to-date knowledge.
Interactive Learning
Workshops and real-world simulations turn abstract concepts into skills you can use immediately.
Tailored for You
Each topic is crafted to address the challenges you face in quality control and assurance.

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).