Pharma Computer Software Assurance 2023 conference held in Mumbai
The event explored various aspects and approaches for CSA and CSV in the pharma industry, providing insights from a regulatory as well as manufacturing perspective
The Pharma Computer Software Assurance 2023 conference’s third edition was recently held at Novotel Mumbai, Juhu Beach, on 22-23 June, 2023.
The conference commenced with a Keynote address from Guneet Kaur Hayer, MD, Eminence Business Media. It was follwed by a panel discussion titled “CSV or CSA? CSV to CSA? CSV is CSA?”, moderated by Ken Shitamoto. The panelists for this discussion included Francisco Vicenty from USFDA, Dr Mayur Parmar from Govt of Gujarat, Ravi Kalla from Anthem Biosciences, and Sanjeev Dharwadkar from Pharma Tech Consulting. This session explored various aspects of CSA and CSV approaches in the pharma industry, providing insights from a regulatory as well as manufacturing perspective.
A “Fireside Chat” with Vicenty followed the panel discussion, which enabled the audience to interact and ask questions to the FDA. The day continued with a session delivered by Deepa Pangaonkar from Wockhardt, on “Quality Testing and Evidence” within CSA and CSV. Vivek Bansal from Biological E. then led a session on “Change Control and Change Management,” to explain the transition from CSV to CSA.
During the conference, partners such as Persistent Systems, Techsol Life Sciences, RxCloud, Rephine, and Conval Group participated in a networking session. Additionally, Kalla designed a process activity for the delegates, promoting collaboration and emphasising the importance of unified systems.
The second day of the conference commenced with a session on Digital Validation Systems by Khaled Moussally from Compliance Group. This session highlighted the significance of going paperless and explored various platforms offering practical solutions. Subsequent sessions focused on facilitating the transition from CSV to CSA. Shitamoto delivered a vital talk on Critical Thinking, followed by a session by Pranav Gadre from Reliance Life Sciences, who shared his experiences of working in IT and QA teams.
The latter half of the day concentrated on topics such as Industry 4.0 and Data Integrity Risk Assessment (DIRA) designed by Rajesh Thempadiyil from Dr Reddy’s Laboratories through a group exercise that stimulated discussions and generated vital takeaways.
The programme concluded with an activity designed to encourage delegates to ask questions in a rapid-fire fashion. The representatives debunked over 100 myths within 45 minutes.
Eminence Business Media plans to announce the dates for the fourth edition of the Computer Software Assurance in 2024, stay tuned for updates on their LinkedIn page and event website.
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