Computerized Systems Validation

Our Conference on Computerized Systems Validation is coming up and you are kindly invited to book the date in your calendar:

Wednesday, 29 September 2021

11:30 – 16:00 CEST (online event)

organized by Pharmalex

Participation in the event is free of charge, but registration is required

“Whoever says, compliance is expensive, should try it without.” – Computerized Systems Validation (CSV) is a topic that continues to stay in the focus as critically important for robust and reliable data generation in scientific research as much as for effective performance of operational activities in biotech R&D and pharmaceutical industry. During the Biotech Atelier 2021 we are coming back to CSV to build up on the sessions held in previous editions with new developments in this area accelerated so rapidly by the immense digital transformation of recent years as a result of changes in global health, economic and technological environment.

This year objective is to present Computerized Systems Validation from different perspectives supporting better understanding of the triggers for development and trends as well as the impact on system compliance and software assurance.

We will provide an overview of new approaches to CSV and current status of their implementation, usage and control, as well as the most efficient ways to handle changes.

Be innovative and at the same time maintain compliance and integrity. It has always been a challenge to get innovation and compliance working together. In the session we shall discuss how the innovative solutions meat the conventional regulatory requirements presenting different strategies and approaches depending on the baseline, resources and objectives.

Solutions recommended or defined by the regulatory guidance will be presented from the industry perspective together with the corresponding developments in real life of pharmaceutical industry where CSV is an integral part of Quality Assurance embedded in all processes and contributing directly to the patient safety and critical product supply.

There will be a panel discussion for participants to raise additional questions and hot topics to the lecturers. It will also be an opportunity to get advices, share or challenge opinions.

The session will conclude with one hour Deep Dive into the best practices providing regulatory details and comprehensive examples of the risk-based approach.

The intended audience of the CSV session is not only among the Subject Matter Experts in Quality, R&D, Production and IT involved in computer validation. The session will also give Managers and Executives a better understanding about the different aspects of current technological development, its impact on regulations and vice versa which is critically important in strategy building, resource allocation and ultimately in making the right business decisions.

Agenda

All times are in Central European Summer Time (CEST) / UTC+2

11:30
 – 11:50

Keynote

Where are we now? Did CSV keep its promises? Is “traditional CSV” still the right approach for new technologies (cloud, AI, ML, etc.)? How can we assure high quality software in an effective and efficient way?

Timm Pauli

11:50
 – 12:20

CSV and CSA - Pharma Industry perspective

Teva Pharmaceuticals

Lidia Karamanova

12:20
 – 13:20

Lunch break

13:20
 – 14:05

Bye Bye Paper

Paperless CSV, Implementing Tools vs Regulation (Challenges), Strategies

Jean-Yves Celis

14:05
 – 14:25

Validating AI/ML Solutions

Rahul Kallampunathil
Ajeeth Veeraraghavan

14:25
 – 14:40

Coffee break

14:40
 – 15:00

Panel discussion

All lecturers

15:00
 – 16:00

Deep Dive session

CSV and Best Practices

Chris Evans
Archie O’Leary

Moderators and Guests

Timm Pauli headshot

Germany

Timm Pauli

Head of Global Regulatory Informatics and Operations
PharmaLex
Organizers
Biotech Atelier logo
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