Eminence Business Media

Eminence Business Media

Saturday, June 24, 2023

Pharma industry strengthening the CSV & CSA approach with the 3rd Annual Computer Software Assurance 2023

The Pharma Computer Software Assurance 2023 conference’s third edition set remarkably high session originality and creativity standards, providing attendees with an engaging program full of valuable learning opportunities. This two-day in-person event occurred at Novotel Mumbai, Juhu Beach, on June 22nd and 23rd, 2023. The conference’s unique program design achieved a balance between CSV and CSA.

The conference commenced with a Keynote address from Eminence Business Media’s Managing Director, Ms Guneet Kaur Hayer. Her warm welcome set the expectations for the exceptional two-day learning program. The program began with an insightful Panel Discussion moderated by Mr. Ken Shitamoto, titled CSV or CSA. Esteemed panellists included Mr. Francisco Vicenty from USFDA, Dr. Mayur Parmar from Govt of Gujarat, Mr. Ravi Kalla from Anthem Biosciences, and Mr. Sanjeev Dharwadkar from Pharma Tech Consulting. This session explored various aspects of CSA and CSV approaches in the pharmaceutical industry, providing valuable insights from a regulatory as well as manufacturing perspective.

Following the panel discussion, attendees had the opportunity to engage in a Fireside Chat with Mr. Francisco Vicenty, enabling direct interaction and the chance to ask questions to the FDA. The day continued with a session delivered by Ms. Deepa Pangaonkar from Wockhardt, focusing on the challenging topic of ‘Quality Testing and Evidence’ within CSA & CSV. Mr. Vivek Bansal from Biological E. then led an engaging session on ‘Change Control and Change Management,’ an essential topic for understanding the transition from CSV to CSA. During the conference, partners such as Persistent Systems, Techsol Life Sciences, RxCloud, Rephine, and Conval Group had the opportunity to participate in a unique networking session. Additionally, Mr Ravi Kalla designed a process activity for the delegates, promoting collaboration and emphasizing the importance of unified systems.

The second day of the conference commenced with an intriguing session on Digital Validation Systems by Mr 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. Mr Ken Shitamoto delivered a vital talk on Critical Thinking, followed by Mr Pranav Gadre from Reliance Life Sciences, sharing his experiences 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 Mr Rajesh Thempadiyil from Dr. Reddy’s Laboratories through a group exercise that stimulated intense discussions and generated vital takeaways.

True to the distinctive nature of the Eminence Conference, the program concluded with a unique

and invigorating activity designed to encourage delegates to ask questions in a rapid-fire fashion. The representatives debunked over 100 myths in an impressive feat within 45 minutes. The day concluded with a unique networking activity, where delegates and speakers could bond over cold beers and 360° Cam experiences.

Eminence Business Media plans to announce the dates for the fourth edition of the Computer Software Assurance in 2024, so stay tuned for updates on their LinkedIn page and event website.