Attestato di partecipazione
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.
The workshop is not focused on the medical device process validation.
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
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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.
This course does not cover process validation for medical devices.
Junior process engineers, production and Quality Control personnel supporting the validation department, Validation and Quality Assurance personnel.
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.
The workshop will be interactive, presenting and discussing case studies and exercises from pharmaceutical manufacturing.
Docente/i
Bianca van de Swaluw
A Quality professional with 23 years working in the pharmaceutical industry. With broad experience in Validation from process validation, cleaning validation, validation of new facilities, equipment validation, analytical method validation to being a project lead qualification/validation.
Online Training – 2 modules
Module 1 | 13 October 2025 from 01:30 pm to 05:00 pm CEST
Module 2 | 14 October 2025 from 01:30 pm to 04:30 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: € 735,00* (until 22 September 2025)
Ordinary: € 925,00*
Freelance – Individual – Academy – Public Administration**: € 530,00*
* for Italian companies: +22% VAT
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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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.
