Introduzione
Production systems for the life science industry must comply with increasingly stricter regulations. Every pharmaceutical and medical device company producing for the European or American market is subject to EMA and FDA requirements and/or local legislation.
Aside from the legislation, the technologies and possibilities used keep evolving at an increasing speed. Computer systems are integrated with each other, creating a more complex landscape, which could not be imagined before.
GAMP (Good Automated Manufacturing Practice), is not another legislation, but a practical interpretation of the legislation and is seen as a structured and project-based approach for validating computer systems.
The latest GAMP5® second edition update emphasizes the importance of computer system assurance above computer system validation.
This in-depth 4-session training will provide you with a fundamental basis to engage yourself in Computer System Validation (CSV) projects and will show you the differences in focus between CSV and Computer System Assurance (CSA).
The workshop will be interactive, presenting and discussing several case studies and exercises.
Module 1
Introduction to CSV/CSA:
- Definition and differences
- Regulatory and guidelines requirements
Module 2
From User Requirements to System Development:
- How to define user requirements and identify proper user requirements
- How to convert user needs and desiderata into computer system functionalities during its development
Module 3
From System Development to Release
Module 4
Case studies and Q&A
Personnel working in Validation, CSV, Quality Assurance, Production, or IT departments and willing to improve their knowledge to better manage future projects in the CSV/CSA area.
The online training will be a mixture of theoretic presentations, case studies and practical examples.
Docente/i
Pieter Smits
Pieter Smits is a senior project manager and project governance lead at the QbD Group with over 10 years of experience in the life science industry. He supported dozens of companies with CSV/CSA projects and enabled multiple companies to bring their software as a medical device to the market. He believes software and automation are for the benefit of the patient executing and performing tasks better and faster than any humans can but not without the required oversight from a quality standpoint.
Online Training – 4 modules
Module 1 | 19 November 2024 from 01:30 pm to 05:30 pm CET
Module 2 | 21 November 2024 from 01:30 pm to 05:30 pm CET
Module 3 | 26 November 2024 from 01:30 pm to 05:30 pm CET
Module 4 | 28 November 2024 from 01:30 pm to 05:30 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: € 1490,00* (until 29 October 2024)
Ordinary: € 1690,00*
Freelance – Individual – Academy – Public Administration**: € 1000,00*
* 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.
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.