Quality Statistics in the Pharmaceutical Industry - Hands-On with Minitab
Highly Interactive Training: Hands-On demonstrations with Numerous Exercises
19/20 May 2026, Hamburg, Germany
Course No. 22700
Speakers
Dr Christian Palmes
Bayer AG
Dr Raluca Ilinca Schmitt
Bayer AG
Case Studies: Outlier Detection in Tablet Weights · Stability Testing (ICH Q1) · HPLC System Validation · pH Control in Continuous Production · Filtration Rate Optimization · Verification of Process Improvements
Prerequisites: Each participant should bring a laptop with a current version of Excel and Minitab installed. A time-limited free trial of Minitab is available from https://www.minitab.com. This program should be downloaded a few days before the start of the course and verified to work properly on the Laptop.
Target Group
This course is ideal for employees in development, quality control labs, process engineering, quality assurance /quality management, production, and validation departments who are currently applying or plan to apply quality statistics methods in their work. It is also suitable for GMP auditors, inspectors, and validation personnel who interact with statistical data or evaluate results in the context of quality and process performance. Requirements: Basic math understanding and a genuine interest in understanding and applying quality statistics in practice.
Objectives
Our quality statistics course offers a clear, hands-on introduction to key statistical methods used in process and quality improvement, with a strong focus on practical application in a pharmaceutical context. The course features six case studies presented in a click-through manner. Statistical concepts are taught at a practical level to ensure participants understand the methods, interpret Minitab outputs correctly, and draw sound, data-driven conclusions.
Day 1: Introduction to Statistics and Minitab, Correlation and Regression Analysis, Hypothesis Testing
Day 2: Measurement System Analysis, Gage R&R, Statistical Process Control and Process Capability, Design of Experiments
This training enables participants to enhance process understanding, justify parameter selections scientifically, optimize analytical workflows, and maintain robust quality throughout the product LifeCycle.
Background Quality statistics is a fundamental discipline in GMP like Quality by Design (QbD) and continuous improvement frameworks such as Six Sigma. It provides the analytical foundation for understanding, monitoring, and improving process performance and product quality. Statistical methods enable organizations to make data-driven decisions, reduce variability, and keep processes capable of meeting specifications. In practice, quality statistics cover a broad range of methods, from descriptive and inferential statistics to advanced tools such as control charts, process capability analysis, measurement system analysis, regression modeling, and design of experiments. These methods are essential for identifying sources of variation, distinguishing between common and special causes, and quantifying the impact of process factors on critical quality attributes. The application of quality statistics spans the product lifecycle – from development to manufacturing and continuous improvement. Its systematic use supports regulatory expectations for scientific and risk-based process understanding as described in ICH Q8, 9, 10, 11 and 14, forming a cornerstone of data-driven quality management in the pharmaceutical Industry.
Programme
Day 1 Welcome and Setting Up the Scene
A short introduction round
Objectives of the Training
Introduction to Statistics
Population and sample
Sources of variation
Statistical measures (mean, median, quantile, range, variance, standard deviation)
Probability (binomial distribution, normal distribution, skewness, z-values, independence)
Introduction to Minitab
Graphical user interface: Project, worksheets, data types
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Social Event On 19 May 2026, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees (per delegate, plus VAT) ECA-Member: € 1890,- Non ECA Member: € 2090,- EU/GMP Inspectorates: € 1045,- APIC Member Discount: € 1990,-
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Please Note: The number of participants is strictly limited due to the workshop format.
Conference language The official conference language will be English.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Testimonials
