Data integrity & Automation

CSA and QbD - ICH Q8, Q9 and Q10 - Risk management - fully automated system - GMP

ONLINE

Date

15 April 2021

Format

Webinar

Why this webinar on Data Integrity?

Data Integrity is a fundamental requirement for the pharmaceutical world, as decisions and assumptions about product quality and compliance with applicable regulatory requirements are made on the basis of data.
Every day, the quality control laboratory generates a huge amount of raw electronic and paper data and it is a huge daily challenge to ensure its full integrity.

In fact, it is no coincidence that in July 2014 the US Food and Drug Administration (FDA) issued a stern warning about the importance of Data Integrity in its ongoing regulatory enforcement efforts. In January 2015, the UK’s MHRA (Medicines and Healthcare Products Agency) published ‘GMP Data Integrity Definitions and Guidance for Industry’ on Data Integrity guidelines.
Through the speakers involved we will try to analyse the key concepts of Data Integrity.
Among these is the increased focus on quality in the validation of information systems by the world’s leading organisations, which is increasingly driving a significantly different approach to what we have been used to seeing in recent years. We will address the chapter on documentation and testing with a specific focus on critical (strategic) thinking and risk Management. We will address, with caution, the interesting scenarios opened by CSA (Computer Software Assurance) because the Supervisory Bodies have not taken an official position and consequently the attitude of the Authorities during Inspections is something we will only discover in the future.

This is why the Italian Committee of A3P has decided to organise this first meeting dedicated to this topic.
Because as regulators continue to refine their approaches to inspection, it becomes critical for those working in GxP regulated laboratories to understand the key issues surrounding Data Integrity and be able to demonstrate compliance with regulations.

Official language of conferences : Italian / English
Simultaneous translation of conferences : Italian <-> English

Thursday 15th April

Webinar Data integrity & Automation
Introduction
09:50
CSA and QbD: new trends in computer system validation
Gilda D'Incerti - PQE
10:00
Data integrity in the microbiology laboratory and new expectations
Félix A. MONTERO-JULIAN - BioMerieux
10:30
Automation of a plant for the extraction of vegetable raw materials in a 4.0 perspective with preparation for compliance with FDA ALCOA+ requirements for Data Integrity
Lorenza COLOMBO - EPO srl & Giuseppe DELLA MURA - EPO srl
11:00
End of the Webinar Data integrity & Automation
11:30

Speakers / LinkedIn

Gilda D’Incerti / PQE  

Félix A Montero-Julian / BIOMERIEUX 

Lorenza Colombo / EPO  

Giuseppe Della Mura / EPO  

Registration form

Webinar A3P Data integrity & Automation

Price :  Free for A3P members  /  120€ excl. tax for non-members

All our webinars are conducted via videoconferencing, which requires a computer with a stable internet connection.

 Accessibility

We use TEAMS (Microsoft Office) or ZOOM software to conduct our webinars. These secure and free collaborative platforms allow you to follow and interact with our expert, guests and other participants in the best conditions. These software are compatible with all operating systems (Windows / ios) and offer an online version compatible with many browsers (Internet Explorer, Chrome, Firefox, Safari, etc.).).

The A3P team is at your disposal to accompany you and ensure the proper functioning of your system remotely. To do so, all you need is a computer, ideally with a headset (optional you can use your computer’s micro/audio system) and a stable internet connection.

A few days before the date of the webinar, you will receive an email invitation to access the TEAMS or ZOOM platform. On the “D” day, you will just have to connect via the link. Please make sure to have a quiet and comfortable place to follow this module in the best conditions.

Contact

For further information please contact Natalina SEMEDO :

Téléphone : +33 (0)4 37 28 30 52
Email : nsemedo@a3pservices.com