Introduzione
Sterilization is an essential process within the pharmaceutical industry used worldwide for sterilizing numerous products. From medical supplies, media to process equipment. Different products require different ways to achieve sterility.
What does “sterile” actually mean? What does it stand for? How do I achieve sterility and how can I validate such a process?
During this training, we will address all these questions and go through a diversity of sterilization processes and how to use them.
Secondly, we will focus on the validation strategies for the different sterilization processes.
Following topics will be part of the course:
- Which sterilization methods can be used in a pharmaceutical production environment?
- What are the characteristics of the different sterilization methods?
- Sterilization Validation
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- Terminology explained: SAL, F-value, Z-value, D-value, BI
- Validation in practice
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- Distribution/mapping studies: materials to be used and approach
- Biological studies: materials to be used and approach
- When is a validation run successful?
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The workshop will be interactive, presenting and discussing case studies and exercises.
Junior process engineers, production and Quality Control personnel supporting the validation department, Validation and Quality Assurance personnel.
The online workshop will be a mixture of theoretic presentations, case studies and practical examples.
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 Process 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 | 12 November 2024 from 02:00 pm to 05:00 pm CET
Module 2 | 14 November 2024 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 22 October 2024)
Ordinary: € 810,00*
Freelance – Individual – Academy – Public Administration**: € 490,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – 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.
Registrati
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.