The 4th Computer Software Assurance 2024: CSx - Define your Variable and Assure your Validation, held by Eminence Business Media on June 20th-21st, 2024 at Radisson Blu Mumbai International Airport, was a resounding success. The event featured over 100 delegates, and industry leaders offering tailored solutions to streamline the CSV process for pharma companies. With dedicated Q&A rounds, presentations, and case study discussions throughout the day, the event proved to be both informative and interactive.
Inaugural Day Highlights
The event commenced with a ceremonial lamp lighting by notable figures such as Mr. Ken Shitamoto, Executive Director IT Quality and Compliance at Gilead Life Sciences, Mr. Biju George, Head IT GMP Operations & CSV at Alembic Pharma, Mr. Yogesh C. Jagtap, Principal e-Compliance Specialist at Dr. Reddy’s Laboratories, and Ms. Guneet Kaur Hayer, Managing Director of Eminence Group.
Ms. Guneet Kaur Hayer delivered an inspiring welcome note, underscoring the importance and challenges of Computer Software Validation/Assurance. Her address set an enthusiastic tone for the event.
Day 1 : Current Trends, Challenges, and Regulatory Frameworks
• Workshop by Mr. Ken Shitamoto: Mr. Shitamoto led a group activity on advanced testing techniques, comparing pre-defined scripts with ad-hoc testing, and discussing the application of CSA/SV principles using agile thinking.
• Industry Presentations :
• Nandhini Natarajan: Shared insights on CSA transformation using AI in pharma testing, focusing on efficiency, accuracy, and compliance.
• Yogesh C. Jagtap: Discussed regulatory frameworks and strategies for staying compliant, including regulations triggering CSA/CSV like 21CFR 211.68 & EU Volume 4/Ch 3.
• Sarada Ramamoorthy: Explored the step-by-step implementation of GAMP principles in software development and validation.
• Ragavan Sundararajan & Rangarajan Rajamani: Highlighted the top forces driving CSA transformation, emphasizing a shift from processes to behaviours and fostering critical thinking.
• Panel Discussion: Moderated by Mr. Ken Shitamoto, the session featured insights from experts on future readiness in CSV/SA, including Mr. Munish Kumar Sharma and Mr. Biju George.
Day 2 : Data Governance, Security, and Integrity
• Roadmap to Successful CSA Implementation: Deepa Pangaonkar focused on creating a CSV quality culture and CSA mindset, sharing a live case study.
• Rishabh Tripathi: Addressed maintaining data integrity and compliance through robust data governance frameworks and the risks associated with data breaches.
• Yogesh C. Jagtap: Covered agile and SCRUM technology, illustrating successful agile methodology implementation with a case study from Dr. Reddy’s.
World Yoga Day: Balanced Mind & Body, Successful Validations
Gayatri Singh, a renowned Yoga and Mindfulness Instructor, led a session to relax attendees' minds and bodies, highlighting the benefits of a calm mind for enhanced productivity.
Case Study Session
Deepa Pangaonkar and Nitesh Gaonkar led a brainstorming session, solving case studies on online SCA implementation on production equipment and validating document management systems applying CSA.
Acknowledgments: Celebrating Partnerships and Collaborations
The event's success was supported by esteemed partners such as Archimedis, Sikich, and media partners, whose contributions were invaluable in advancing quality standards in the pharma industry.
Conclusion : Inspiring Change and Driving Collaborations
As the 4th Computer Software Assurance 2024 concluded, participants left feeling rejuvenated and motivated. The event provided valuable insights, collaborations, and practical knowledge, paving the way for positive change and transformation in the pharmaceutical landscape.
