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
Jonathan Boel
Info

Jonathan Boel

Software services & solutions division head – QbD

Jonathan Boel is the division head for software services and solutions within the QbD group. Next to this leadership role Jonathan is a senior project manager, auditor and internal trainer at the QbD group. With more than 12 years of experience in the life sciences sector, he can bring a lot of concrete and pragmatic expertise towards computer system validation, computer system assurance, and data integrity, whether for the pharmaceutical industry or the Medical Device and In vitro Device Industry.
Pieter Smits
Info

Pieter Smits

Project Manager – QbD

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 1:30 pm to 5:30 pm CET
Module 2 | 21 November 2024 from 1:30 pm to 5:30 pm CET
Module 3 | 26 November 2024 from 1:30 pm to 5:30 pm CET
Module 4 | 28 November 2024 from 1:30 pm to 5:30 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**: € 950,00*

* 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
Early bird
Acquistabile fino al 29/10/2024
€1.490,00
Ordinaria
Acquistabile fino al 18/11/2024
€1.690,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 18/11/2024
€950,00
Svuota
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Participate in computer systems validation projects
Risultato atteso
Develop yourself as a computer systems validation expert
<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>
Vedi tutte le edizioni
Computer System Validation (CSV) and Assurance (CSA)