Introduzione
In pharmaceutical manufacturing, the approach to validation has evolved over the years.
The idea of relying entirely on the analysis of three pre-market validation batches was not sufficient to guarantee the effectiveness and quality of the process and has been abandoned. On the contrary, it is generally accepted that validation is a continuous process throughout a product's life cycle even after being placed on the market.
Validation as a “Life Cycle Process” includes 3 main stages:
- Stage 1: Process Design
- Stage 2: Process Qualification/ Demonstration
- Stage 3: Continued Process Verification
Where stage 2, which corresponded to the old validation approach, represents now only a small part of the entire process.
This workshop aims to provide insights into this continuous validation approach, describing how these new requirements can be achieved, according to and fitting both FDA and European guidelines.
The course will address and discuss how to demonstrate sound knowledge and understanding of the process based on the studies carried out in the development phase, which parameters to be used, when a process can be considered validated and how “ongoing process verification” can be realized.
Programma
The following topics will be part of the course:
- The evolution of Process Validation in a nutshell
- Difference between Qualification and Validation
- FDA versus EMA expectations
- The 3 stages of Process Validation
- Stage 1: Process Design
- QTPP, CQA and CPP explained
- Process Risk Management
- Control strategy
- Stage 2: Process Qualification
- PPQ explained
- Protocol and report
- Stage 3: Continued Process Verification
- How to keep the process in a validated state
- Stage 1: Process Design
The workshop will be interactive, presenting and discussing case studies and exercises from pharmaceutical manufacturing.
This course does not cover process validation for medical devices,
Docente/i
Stan Van Kerkhoven
Stan Van Kerkhoven is a Bio-Engineer with also a Master in Business Economics who graduated in 2006. During his 20 years of career he held several roles in Validation and was during 5 years the Cleaning Validation Specialist of MSD in Small Molecules. Besides his period at MSD he was also responsible for implementing Cleaning Validation at Estée Lauder. Besides Cleaning Validation he was also responsible for Equipment, Process, Sterilisation and Computer System Validation at different pharmaceutical companies like Sanofi, Organon, Estée Lauder, MSD and J&J.
In 2026, he joined the QbD Qualification and Validation team, where he became a Senior Project Manager in January 2026. In his free time, he likes to go on fishing trips, play snooker with his friends and enjoys time with friends and friends.
Informazioni utili
The course will take place online on Zoom platform.
It will be activated in live online mode once a minimum number of interested people has been reached.
Registration Fee
Early Bird: € 755,00*
Ordinary: € 945,00*
Freelance – Individual – Academy – Public Administration: € 535,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
A chi è rivolto
- Junior process engineers.
- Production and Quality Control personnel supporting the validation department.
- Validation and Quality Assurance personnel from pharmaceutical manufacturing.
Participant experience
It is recommended a basic experience in biopharmaceutical manufacturing as personnel working in process development/engineering, production, Quality Control, Quality Assurance and Validation department.
Tecniche didattiche
The workshop will be interactive, presenting and discussing case studies and exercises from pharmaceutical manufacturing.
Il corso verrà avviato in modalità live non appena raggiunto un numero minimo di partecipanti. Lascia i tuoi dati per essere contattato non appena il corso sarà disponibile.
Cosa saprai fare dopo il corso
