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Pharma Quality Reimagined: Highlights from the 5th Annual Pharma GMP & Quality Management 2025
hits:31 Date:05/09/25
The pharma world came together once again at The Westin Mumbai Garden City on April 24th - 25th, 2025, for the highly anticipated 5th Annual Pharma GMP & Quality Management 2025, hosted by Eminence Group. Against the buzzing backdrop of Mumbai, industry leaders, innovators, and regulators convened to explore the future of quality, compliance, and digital transformation in life sciences.
From insightful keynotes to lively workshops and deep-dive panels, the event lived up to its promise: "Empowering the Pharma Industry for Tomorrow."
Ms. Guneet Kaur Hayer, Managing Director of Eminence Group, welcomed the audience with a stirring address emphasizing the need for proactive quality strategies, workforce transformation, and embracing digital evolution.
Key Themes and Memorable Conversations
The first morning took off with Dr. Damodharan M from Sai Life Sciences, who offered a panoramic view of how evolving global GMP regulations are shaping the compliance landscape. His session urged companies to prepare not just for today's audits, but for a future driven by sustainability and technological integration.
Immediately after, Aditya Chaudhary from Hexagon ETQ explored the digital revolution within pharma QMS. He emphasized how cloud-based, integrated systems could future proof organizations by automating regulatory reporting and enhancing traceability.
Learning by Doing: Workshops that Engaged
The conference shifted gears into practical learning with Ken Shitamoto from Gilead Lifesciences leading a mock inspection session. Attendees, role-playing as inspectors and auditees, learned firsthand what regulators scrutinize from documentation practices to operational transparency.
Building on this, Digambar Nigade from Amneal Pharma navigated participants through actual recent FDA 483 observations. He dissected real-world pitfalls and helped attendees shape strategies for avoiding compliance gaps.
Meanwhile, leaders from Veeva Systems, Varadarajan Srinivasan and Pradeep Nagisetty, shared inspiring case studies on migrating from outdated, siloed quality systems to integrated cloud-based platforms proving that digital transformation is not optional, it is essential.
Real-World Insights: Risk Management and Deviation Handling
Dr. Udaykumar Rakibe (Pharma Mantra) took a practical approach to Quality Risk Management, using live case studies to demonstrate how frameworks like FMEA and HACCP should be applied across pharma processes.
In a hands-on workshop, Prashanth GN of Granules India immersed attendees into the nuances of deviation management. Through group activities, participants tackled real-world scenarios, strengthened their root cause analysis skills, and discussed best practices for CAPA documentation.
As the day wrapped up, Ranjit Barshikar (CEO, ObD International) delivered an impassioned session on building a culture of quality by strengthening internal teams through structured training and skill-gap assessments.
Day 2: The Future Beckons — Smart Labs, Gen AI, and Cyber Resilience
Day 2 opened with a fascinating live case study from Dr. Amjad Basha (Dr. Reddy’s Labs) on smart lab transformation. His real-world example of digitizing R&D environments offered practical lessons on overcoming adoption challenges.
The technology thread continued with a high-energy panel led by Archimedis Digital's leadership team starting with Duraisamy Rajan Palani, Anand Govindarajan, and Jeyashri Thivari exploring how AI, digital twins, and augmented reality are revolutionizing quality assurance and compliance.
A pivotal moment arrived with the star-studded panel featuring Ken Shitamoto, Abhijit S. Kulkarni (Lupin Limited), Shirish Ambulgekar (Alkem Laboratories), and Amit Malviya (Zest Pharma). They passionately debated how Gen AI is transforming the pharma workforce, operational efficiency, and supplier management, while cautioning about responsible adoption.
AV Jayakumar from Ajanta Pharma shifted the spotlight onto contamination control, detailing how companies can align with the revised EU GMP Annex 1 by building robust Contamination Control Strategies (CCS) based on risk assessment and facility design principles.
In a refreshing break from technical discussions, the audience participated in the #EminenceDigitalDetox session. A unique wellness initiative by Eminence Business Media aimed at boosting mental agility and resilience in high-pressure GMP environments.
Closing the day was a critical conversation on cybersecurity. Guneet Kaur Hayer, along with leaders like Dr. A.R.M. Rao (Aurobindo Pharma), Chitti Babu (Aurobindo Pharma), Sanjeev Mahajan (Innova Captab), and Pushkar Lakhekar (Cohance Lifesciences), outlined best practices for building cyber-resilient Quality Management Systems in an increasingly digitalized pharma world.
Acknowledgments: Celebrating Partnerships and Collaborations
Eminence Group extends heartfelt gratitude to all event partners whose support made this conference possible:
- Gold Partner: Veeva Systems
- Digital Transformation Partner: Archimedis Digital
- Silver Partner: Hexagon ETQ
- Exhibit Partners: Arcolab, Astakenis, Mactus Automation Pvt. Ltd., SEEK and AmpleLogic
Their contribution not only fuelled the event's success but also underscored the collaborative spirit needed to transform pharma's future.
Moving Forward Together
As the conference concluded, one thing was clear: the future of pharma quality will be shaped by those who embrace innovation, invest in people, and stay agile in a rapidly evolving regulatory environment.
The Eminence Group thanks all participants, speakers, and partners for making the 5th Annual Pharma GMP & Quality Management 2025 a resounding success and looks forward to an even more transformative 6th edition in 2026! |
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