Introduzione
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 biopharmaceutical 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.
The workshop will focus mainly on drugs. However it will give some tips on the main process of cleaning validation of medical devices.
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?
- How is the Cleaning Validation Process performed on medical devices? A brief overview.
- Stage 1: Process Design
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
Rik Seymus
Rik has more than 20 years of experience in the validation department, having worked in several pharmaceutical companies, including Novartis and Genzyme/Sanofi. As Validation Engineer and Manufacturing Support Engineer he has participated in several projects, focused on process and cleaning validation.
Rik has been working for 2 years at QbD group, as Senior Validation and Qualification Engineer and is the Review Team Lead for the CAR-T project Ghent.
Online Training – 2 modules
Module 1 | 28 October 2025 from 02:00 pm to 05:00 pm CET
Module 2 | 29 October 2025 from 02:00 pm to 05:00 pm CET
After the registration, 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: € 680,00* (until 08 October 2024)
Ordinary: € 870,00*
Freelance – Individual – Academy – Public Administration**: € 495,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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Mara Claudia Algarotti
Training Manager & MW Operations
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.