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.
