Introduzione
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 now generally accepted that validation is a continuous process throughout a product's life-cycle even after it has been 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, and describe how these new requirements can be achieved, in compliance with 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.
The following topics will be part of the course:
- The evolution of Process Validation in a nutshelf
- Difference between Qualification and Validation
- FDA versus EMA expectations
- The 3 stages of Process Validation
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- 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.
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 theoretical 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 | 01 October 2024 from 02:00 pm to 05:00 pm CEST
Module 2 | 02 October 2024 from 02:00 pm to 05:00 pm CEST
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 10 September 2024)
Ordinary: € 810,00*
Freelance – Individual – Academy – Public Administration**: € 490,00*
* 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.
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.
