Introduzione
Ensuring Excellence in (Bio)pharmaceutical Cleaning Validation
Good Manufacturing Practices (GMP) consider cleaning validation to be of paramount importance in the manufacture of medicinal products and medical devices.
Indeed, cleaning validation is a relevant activity to prevent contamination of (bio)pharmaceutical products by ensuring that the processing equipment is suitable for subsequent manufacturing processes. Potential contaminants like API, degradation products, impurities, bioburden and endotoxins will be considered, as well as possible cleaning solvent residues.
This course will provide the meaning and the principles of possible cleaning validation strategies, also describing the most common sampling and detection techniques used for these activities.
Programme
The following topics will be part of the course:
- Which cleaning methods can be used in a pharmaceutical production environment?
- How do the cleaning methods work?
- The 3 stages of Process Validation applied to Cleaning Validation of drug product manufacturing
- Stage 1: Process Design
- Determination of worst-case location
- What are the important cleaning steps and critical parameters?
- Determination of cleaning effectiveness: sampling method, detection method and acceptance criteria
- Stage 2: Process Qualification
- Pre-requisites
- What’s included in the protocol?
- Stage 3: Continued Process Verification
- How to keep the Cleaning Process in a validated state?
- Stage 1: Process Design
- How is the Cleaning Validation Process performed on medical devices? A brief overview.
The workshop will be interactive, presenting and discussing case studies and exercises.
Junior process engineer, production and Quality Control personnel supporting the validation department, Validation and QA personnel.
Participant experience
Basic experience in biopharmaceutical manufacturing as personnel working in process development/ engineering, production, Quality Control, Quality Assurance and validation is recommended.
The online workshop will be a mixture of theoretical presentations, case studies and practical examples from the real-world of drug production and 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.
Online Training – 2 modules
Module 1 | 27 October 2026 from 02:00 pm to 05:00 pm CET
Module 2 | 28 October 2026 from 02:00 pm to 05:00 pm CET
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 690,00* (until 06 October 2026)
Ordinary: € 880,00*
Freelance – Individual – Academy – Public Administration**: € 495,00*
*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.
Newsletter
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
