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CESPE Academy Courses

GAMP Training

Course takes place from 17th to 18th of June 2025 at the Faculty of Pharmaceutical Sciences.

COURSE OVERVIEW

Interested in expanding your knowledge of Good Automated Manufacturing Practice (GAMP), Computerized System Validation, Regulations, and more? Experts from QbD Group will be instructing a 2-day training that will do exactly that. Check the information on the course below to decide if it suits your needs!

Production systems for the pharmaceutical and food industries have to comply with ever-stricter legislation. This training not only offers you theoretical knowledge of the basic aspects of GAMP – with a focus on the detailed life cycle – but also offers multiple practical exercises.

Additionally, a test will be provided so that you can check if you can apply your gained knowledge.The course begins with an introduction to GAMP principles and gradually builds to more complex examples and exercises.



Course has a 2-day programme:

Day 1

The following will be addressed:

Introduction to GAMP

Detailed Lifecycle

Regulations (21 Cfr part 11; Annex 11)

Extended Exercises on Validation, Specifications, Risk Assessment

Day 2

The following will be addressed:

Detailed Lifecycle and Verification Reporting

Operational Phase

Extended Exercises on Test Execution and Report, Validation, Requirements Matrix



COURSE PROGRAMME

An overview of the course programme can be found in the following document.


Registrations are open for this course, please follow the ‘REGISTER HERE’ link above. If you have any questions please email Mark Gontsarik (mark.gontsarik@ugent.be).

Categories
CESPE Academy Courses

Design of Experiments (DOE)

Course takes place on 9th and 10th of September 2025 at the Faculty of Pharmaceutical Sciences, Ottergemsesteenweg 460, 9000 Gent, Belgium.

COURSE OVERVIEW

The DOE training is hands-on and designed for individuals who want to actively engage in Experimental Design and gain a better understanding of the statistical analysis of experimental data. The course emphasizes the Optimal Design of Experiments, matching the experimental design to the problem while considering all experimental boundary conditions and constraints. Optimal DOE is computer-aided, meaning experiment runs and regression models are generated by computer algorithms; the software package used is JMP. The topics are illustrated through case studies and examples from industrial R&D, making the training particularly relevant for professionals in that field.

The course is divided into two modules, each lasting one full day. The basic module begins by covering the necessary theory, including basic training in linear multiple regression analysis for analyzing experimental data and establishing statistical process models needed for parameter screening and optimization. Additionally, the JMP software package will be introduced, and simple cases will be reviewed to describe the basic DOE approach. The advanced module covers more complex examples with specific experimental conditions. In each of the case studies, the goal is to improve the performance of a process or product through efficient exploration and optimization.



COURSE PROGRAMME

A detailed overview of the different modules can be found in the following document.


Registrations are open for this course, please follow the ‘REGISTER HERE’ link above. If you have any questions please email Mark Gontsarik (mark.gontsarik@ugent.be).

Categories
CESPE Academy Courses

Sustainability and Life Cycle Assessment: From Theory to Practical Applications in Pharma

The last iteration of this course took place from 7th to 9th of May 2025 at the Faculty of Pharmaceutical Sciences, with a new iteration is on the way in 2026!

COURSE OVERVIEW

The Sustainable Systems Engineering (STEN) group offers a comprehensive training programme in Sustainability and Life Cycle Assessment (LCA), with a focus on the pharmaceutical industry. The programme consists of three modules: foundational concepts, practical skills, and industry-specific applications.

The foundational module covers principles of sustainability assessment and the LCA methodology. The practical module provides hands-on experience with LCA software, while the advanced module focuses on applying LCA in the pharmaceutical sector, including case studies and modeling challenges. Through lectures, case studies, and interactive sessions, participants gain essential knowledge and skills to perform sustainability assessments, with an emphasis on practical applications and critical thinking about sustainability in the pharmaceutical field. Moreover, practical expertise in the LCA process empowers decision-makers to fully comprehend the insights derived from the analysis, enabling them to make more informed and sustainable choices.



Course has a 3-day programme, split into 3 modules:

Module 1: Theoretical framework of Life Cycle Assessment (1 day)
Module 2: Practical case studies (1 day)
Module 3: Advanced module on LCA in pharma sector (1 day)

MODULE 1: Theoretical framework of Life Cycle Assessment

The following will be addressed:

Introduction to Sustainability and Life Cycle Thinking

Integrating environmental, social, and economic aspects: LCSA and S-LCA

Principles and framework of Life Cycle Assessment (ISO 14040 series)

Goal and Scope in LCA, Life Cycle Inventory, Life Cycle Assessment, and Interpretation

MODULE 2: Practical case studies

The following will be addressed:

LCA software tools

Introduction to specialized software: OpenLCA

Use and explanation of the different databases

Practical case studies in OpenLCA

Analyzing and interpreting results

MODULE 3: Advanced module on LCA in pharma sector

The following will be addressed:

Green Chemistry and process level assessment metrics

Conducting LCA in pharma sector
LCA tailored to pharmaceuticals
Challenges (data collection, methodological choices, accounting for ecotoxicity, etc.)
Concrete case studies

Beyond LCA of classical drug products & environmental sustainability assessment


COURSE PROGRAMME

An overview of the different modules can be found in the following document.


Registrations are open for this course, please follow the ‘REGISTER HERE’ link above. If you have any questions please email Mark Gontsarik (mark.gontsarik@ugent.be).

Categories
CESPE Academy Courses

Towards Continuous Lyophilization: from Formulation to In-Line Analysis

COURSE OVERVIEW

Towards Continuous Lyophilization course provides a comprehensive introduction to pharmaceutical freeze-drying through an engaging mix of theoretical and hands-on training.
This one-day course equips trainees with a solid understanding of the essential principles, covering the entire process from starting materials to the finished product.
This includes:

  • formulation aspects
  • getting to know the equipment
  • learning to understand the first-principles of lyophilization
    • including both heat and mass transfer mechanisms during freeze-drying

After that,  the most important PAT tools which are commonly used in the field will be covered. Additionally, a novel continuous freeze-drying technology will be explored in detail. Finally, tour of the lab will be provided, along with interactive sessions on modeling and data analysis.

By the end of the course, participants will have a solid understanding of the key principles and processes involved in pharmaceutical freeze-drying. They will gain practical knowledge to design and optimize freeze-drying processes, select appropriate PAT tools, and troubleshoot common issues.


Theoretical

Introduction to Lyophilization

  • Fundamentals of freeze-drying
  • Detailed overview of the freeze-drying process
  • Equipment and components used in freeze-drying

Lyophilization Formulations

  • Purpose and composition of freeze-drying formulations
  • Critical properties of freeze-dried materials
  • Characterization methods for lyophilized products

Modeling the Freeze-Drying Process

  • Introduction to modeling
  • Modeling of freeze-drying and applications
  • Design space for freeze-drying

Process Analytical Technology (PAT) in Freeze-Drying

  • Importance of PAT in freeze-drying
  • Key PAT tools and their application

Continuous Freeze-Drying

  • Advantages and innovations of continuous freeze-drying
  • Limitations of traditional batch freeze-drying

Practical

Tour of the CESPE Freeze-Drying Lab

  • Batch freeze-dryers
  • Continuous freeze-dryers
  • Sample characterization lab

Interactive Modelling Session

  • Hands-on experience in constructing a design space for freeze-drying

Data Analysis Workshop

  • Interpretation and analysis of common freeze-drying data

COURSE PROGRAMME

A detailed overview of the programme can be found in the following document.


If you are interested in taking this course, please email Mark Gontsarik (mark.gontsarik@ugent.be).

Categories
CESPE Academy Courses

Process Control and Optimization

Last course took place on 29th of April 2025 at the Faculty of Pharmaceutical Sciences.

COURSE OVERVIEW

This course addresses the question of how we can keep pharmaceutical processes in optimal manufacturing conditions while ensuring versatility, resilience and quality of end product. Pharmaceutical control systems that are sustainable and balance the ecological footprint with ensuring access to high quality products and maintaining profitable supply chains. This question is part of the larger (international) challenge to ensure sustainable demand and production patterns, by improving environmental and societal sustainability and increasing the circularity in pharmaceutical production systems. This course is divided into two separate modules:

Module 1: Process identification: (1/2-day – morning)
&
Module 2: PID-based process control (1/2-day – afternoon)


MODULE 1: Process Identification

Theoretical

This course will provide interactive learning and real-world application, so you can directly apply what you’re learning to your own context

The following will be addressed:

Fundamentals of process identification
&
Understanding process dynamics
&
Identification at operator level (e.g. first order plus dead time approximation model)
&
Systems identification from relay experiments (PRBS identification)



MODULE 2: PID-based process control

This course will provide interactive learning and real-world application, so you can directly apply what you’re learning to your own context

The following will be addressed:

PID based control for process optimization
&
Auto-tuning methods for PID design
&
Frequency response design for PID design (FRTool)

The session will end with an overview of advanced process control methodologies (e.g. model predictive control, event-based control, etc.) able to ensure plant-wide optimization.


COURSE PROGRAMME

A detailed overview of the different modules can be found in the following document.


Registrations are open for this course, please follow the ‘REGISTER HERE’ link above. If you have any questions please email Mark Gontsarik (mark.gontsarik@ugent.be).

Categories
CESPE Academy Courses

Spectroscopic Modelling Using Python

COURSE OVERVIEW

The Spectroscopic Modelling Using Python training is a hands-on course for building custom spectroscopic models using Python. Techniques like NIR and Raman spectroscopy are powerful tools for non-destructively evaluating chemical and physical sample properties, but proper data processing is key to unlocking their full potential.

This course will be given by experts from elegent, a spin-off company from Ghent University offering modelling services for the pharmaceutical and food industries. 

This course covers essential steps for creating reliable models, introducing key Python modules and demonstrating their use through a pharmaceutical manufacturing case study. Participants will gain a thorough understanding of both theoretical concepts and their practical application in Python.



COURSE PROGRAMME

A detailed overview of the course can be found in the following document.


Registrations are open for this course, please follow the ‘REGISTER HERE’ link above. If you have any questions please email Mark Gontsarik (mark.gontsarik@ugent.be).

Categories
CESPE Academy Courses

Efficient Data Processing Using Python

COURSE OVERVIEW

The Efficient Data Processing training is a hands-on course designed to help participants accelerate their data workflows. Processing large, complex datasets often takes significantly more time than data collection, but this course demonstrates how Python can streamline these tasks for faster analysis and interpretation. This course will be given by experts from elegent, a spin-off company from Ghent University offering modelling services for the pharmaceutical and food industries. 

Through case studies focused on pharmaceutical R&D manufacturing, participants will learn to clean and transform data using Python modules like numpy, pandas, and scikit-learn, along with visualization tools such as matplotlib, seaborn, and plotly. The training integrates theoretical background with practical application, making it especially relevant for scientists and academics in R&D.

By eliminating repetitive tasks, optimizing workflows, and enabling visual analysis of experiments, this course equips participants with tools to enhance efficiency in data processing.



COURSE PROGRAMME

A detailed overview of the different modules can be found in the following document.


Registrations are open for this course, please follow the ‘REGISTER HERE’ link above. If you have any questions please email Mark Gontsarik (mark.gontsarik@ugent.be).

Categories
CESPE Academy Courses

Material characterization

COURSE OVERVIEW

This course gives an introduction on the (pharmaceutical) relevance of (raw) material characterization. An overview is given about the relevant characterization methods on the market, their applicability and how the material properties can be used to describe the processability.
This 1-day course consists out of a theoretical (interactive) and hands-on part.


MODULE 1: BASIC COURSE

Theoretical

The trainee will get an in-depth explanation about the different characterization methods, their (pharmaceutical) relevance and what you can do with the generated data.
Some of the key material characteristics described are:

Flow/cohesion
&
Particle size and shape
&
Density and porosity
&
Electrostatic charge
&
Melting point and crystal structure
&
Viscosity

Practical

Hands-on sessions will allow the trainee to get a feel with what it takes to characterize a material.
The extensive array of characterization equipments, available at CESPE, will be made available to visualize the difference between highly divergent powders.
Some of the equipment that will be used are:

FT4 Powder Rheometer
&
Schulze Ring Shear Tester
&
GranutoolsTM equipment
&
Malvern Laser diffractors
&
DVS and DSC equipment

Upon request, a powder of interest could be tested on the available equipment!
For more information, please contact Sarah.Costers@UGent.be .


COURSE PROGRAMME

A detailed overview of the course can be found in the following document.


If you are interested in taking this course, please email Mark (mark.gontsarik@ugent.be).

Categories
CESPE Academy Courses

Process Analytical Technologies

COURSE OVERVIEW

This course focusses on giving a basic introduction about the implementation of PAT tools in the (bio)pharmaceutical industry.
This course is given in an interactive manner (both theoretical and hands-on) and can be divided into two separate modules:

Module 1: Basic course: Introduction to PAT (1-day module)
&
Module 2: Basic data-analysis and modeling (1.5-day module)

Requirements
Basic understanding of spectroscopy and (bio)pharmaceutical processes
&
Basic understanding of coding and programming (python)


MODULE 1: BASIC COURSE: INTRODUCTION TO PAT

Theoretical

The trainee will get a general introduction to PAT and the common (non-)spectroscopic sensors, learning how, when and where these tools can provide a benefit.

Spectroscopic sensors
&
Non-spectroscopic sensors (Univariate/Multivariate)
&
Hyperspectral imaging
&
PAT in R&D/Process Validation/QbD
&
Regulatory aspects
&
Multivariate data-analysis

Practical

The trainee will get the chance to see how PAT tools can be used/implemented and how this translates in a practical approach to acquire relevant process information.
Some of the tools that will be demonstrated are:

NIR
&
Raman
&
FLIR

MODULE 2: BASIC DATA-ANALYSIS AND MODELING

Theory through practice

Using spectroscopic data, the teacher will go through different aspects of PAT and model development together with the attendee.

General introduction to Python
&
Data preparation and exploration
&
Introduction to modeling
&
Process control based on PAT


COURSE PROGRAMME

A detailed overview of the different modules can be found in the following document.


If you are interested in taking this course, please email Mark (mark.gontsarik@ugent.be).