What and where?
In a world where the fast digital transformation touches every aspect of our daily lives, Computerized System Validation (CSV) is essential for competent risk management, to improve product reliability, to increase patient safety and ensures the systems are running accurately within regulatory requirements. During this year’s business conference – Biotech Atelier 2021, this will be one of the important topics where PharmaLex will take the lead.
On the 29 th of September, from 11:30 until 16:00, PharmaLex 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. This year objective is to present Computerized System 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.
What is the discussion about?
During the session we will discuss how the innovative solutions meet the conventional regulatory requirements presenting different strategies and approaches depending on the baseline, resources and objectives.
The business will present solutions and recommendations defined by the regulatory guidance together with the corresponding developments in the pharmaceutical industry where CSV is an integral part of Quality Assurance which contributes directly to the patient safety and critical product supply. Moreover, there will be a panel discussion for participants to raise questions and express their opinion on the hot topics. The session will conclude with one-hour Deep Dive into the best practices providing regulatory details and comprehensive examples of the risk-based approach.
What is the audience?
The CSV session is intended to Subject Matter Experts in Quality, R&D, Production and IT involved in computer validation, but also for Managers and Executives who will get a better understanding about the different aspects of current technological development and its impact on regulation.
In 2020 Pharmalex has merged with Arbour Group to deliver specialized software testing services and validation solutions to Life Science companies to ensure compliance with applicable regulatory guidance required by the US Food and Drug Administration (FDA), UK Medicines and Healtcare Products Regulatory Agency (MHRA), European Medicine Agency (EMA) and other international regulatory authorities.
Powered by Arbour Group, on the 29 th of September, during the Biotech atelier Conference, we will give answers to the many questions the innovations are raising and specifically the Computerized System Validation.