The 4th Annual Pharma GMP & Quality Management 2024, held at NOVOTEL Mumbai International Airport on April 25th and 26th, emerged as a pivotal event in the pharmaceutical industry landscape, fostering collaboration, innovation, and excellence in pharma quality management. With an impressive lineup of 22 speakers, each bringing their expertise to the forefront and over 190 delegates from over 50 companies, the event offered a holistic exploration of foundational concepts, cutting-edge stra- tegies, and transformative insights.
Day 1: Exploring Foundational Concepts and Cutting-Edge Strategies
The inaugural day of the event commenced with ceremonial lamp-lighting graced by eminent personalities such as Dr. Binh Nguyen, Former FDA Investigator, Mr. SM Mudda, Managing Director, Misom Labs, Mr. AV Jayakumar, EVP - Corporate Quality, Ajanta Pharma, Mr. Subhrangshu Chaudhury, VP and Head - Quality, Centaur Pharma.
Ms. Guneet Kaur Hayer, Founder and Managing Director of Eminence Group, delivered an inspiring welcome note, underscoring the significance of quality culture and excellence in driving sustainable growth and setting the tone for the event. The day unfolded with a series of sessions led by industry experts, each addressing critical aspects of pharmaceutical quality management:
Masterclass by Former FDA
Dr. Binh Nguyen, Former FDA, and Sr. Consultant Lachman Consultants enlightened participants on the Comprehensive Approach to Investigation Processes while Navigating OOS Results Effectively Addressing 483 Observations and Implementing CAPA Strategies.
On Day 2 Dr. Nguyen led a workshop on mastering audit skills, and preparing participants for upcoming audits by highlighting key issues and potential pitfalls and dived into a session 5 scenarios + 5 Solutions where he presented real-life cases from his inspections.
The masterclass sessions provided participants with actionable insights and practical strategies to navigate the complexities of quality management, ensuring compliance, efficiency, and effectiveness in their operations.
Insights and Solutions: Navigating Challenges and Embracing Innovation
Mr. Vipul Doshi, Chief Quality & Compliance Officer, Zydus Life Sciences led an engaging session on Agile Quality Management Systems (QMS), shedding light on the transformative impact of agile methodologies on quality management practices within the pharmaceutical industry.
Following Doshi's insightful presentation, Mr. Mohit Pateriya took the stage to delve into the keys to successfully adopting agile methodologies. Drawing from his extensive experience, he shared practical strategies and best practices for effectively implementing agile frameworks within pharmaceutical organizations. His session provided attendees with actionable steps to navigate the challenges and maximize the benefits of agile adoption.
Continuing the momentum, Mr. Prashant Sharma, CTO, Zydus Life Sciences delivered a thought-provoking session on Workforce Management strategies aimed at reducing GMP recalls. Sharma's session underscored the critical importance of proper resource allocation, skill development, and process alignment in empowering teams to mitigate risks and drive operational excellence. Attendees were inspired by Sharma's innovative approach to workforce management and left with valuable insights to optimize their GMP processes.
Mr. Subhrangshu Chaudhury, VP & Head of Quality, Centaur Pharma shed light on insights from Quality Management Maturity (QMM) Pilot Programs and how Indian Pharma can benefit from them.
Mr. Sanjay Sharma from Zydus Life Science elucidated the importance of product robustness, Continued Process Verification (CPV), and digitalization in maintaining control and enhancing efficiency in pharmaceutical operations.
Dr. Kavita Vengurlekar, VP - Data Excellence, Caliber Technologies delved into the transformative potential of data in pharmaceutical organizations, exploring strategies for harnessing critical insights and cultivating a culture of regulatory compliance.
Mr. Suveer Shrivastava's session on the revision of ICH Q9 and innovative Risk Management approaches offered attendees valuable insights into improving risk-based decision-making processes and enhancing pharmaceutical quality.
The session by Mr. Sushil Barkur was not only informative but also engaging, offering practical strategies for evaluating and mitigating common GMP issues caused by human error. Attendees were drawn into a lively discussion that encouraged active participation and critical thinking. Mr. Barkur's insights provided valuable guidance on enhancing operational efficiency and regulatory compliance, making it a fun and thought-provoking session for all.
Dr. Ramesh Jagadeesan from Recipharm shared insights into cutting-edge Analytical Techniques for Quality Assurance, highlighting advancements in spectroscopy, chromatography, and mass spectrometry.
Mr. Anup Garg explored the secrets of mastering Document Management Systems (DMS) and optimizing document workflows for compliance and collaboration.
In a riveting presentation, Dr. M Damodharan delved into the intricate world of compliance gaps and the transformative power of predictive analytics in anticipating failures within pharmaceutical operations. With captivating examples, Dr. Damodharan show- cased the successful integration of AI technologies, shedding light on how these advancements are reshaping the industry's approach to quality management.
Mr. Varadarajan Srinivasan from Veeva explored the synergy between digital transformation and quality culture, emphasizing the importance of leveraging technology to ensure excellence in quality management.
Mr. Bhavish Agarwal delved into the transformative impact of data analytics on pharmaceutical quality processes. He unveiled a groundbreaking new product, Hedwig AI, designed to empower pharmaceutical leaders in their preparation for audits. Hedwig AI, offers invaluable insights derived from past inspections and reactions, providing a comprehensive toolkit to navigate regulatory scrutiny with confidence and precision. Attendees were intrigued by the potential of this innovative solution to revolutionize their approach to compliance management and enhance audit readiness.
Harmonizing Diverse Perspectives
The fireside chat on Data Integrity provided a fresh perspective on addressing the age-old challenge of maintaining data integrity in pharmaceutical operations. Dr. Vineet Bhushan, CEO & Founder, of Stellar Pharma Solutions moderated the discussion, with panelists Mr. Jayakumar AV, EVP - Corporate Quality, Ajanta Pharma, and Mr. Mohamed Hussain, Sr. Director, Cipla sharing their insights on the critical role of data integrity in ensuring product quality and regulatory compliance.
The event culminated with a captivating discussion on quality culture and world-class excellence, moderated by Dr. Ashok Kumar Bhattacharya, Global Health Care Consultant featuring visionary leaders like Mr. Gopi Reddy, Sun Pharma, Jitendra Kumar Jain, VP – Quality, Amneal, Dr. M Damodharan, CQO, Sai Life Sciences Ltd, and Mr. Hitesh Bhatt, Former VP - Quality, Amneal. The panelists shared their experiences and insights, inspiring participants to embrace a culture of continuous improvement and innovation in their respective organizations.
Acknowledgments: Celebrating Partnerships and Collaborations
The success of the event was made possible by the unwavering support and collaboration of our esteemed partners Caliber Technologies, ECUBIX, VEEVA, AiZenAlgo, Honeywell, FDALytics, and Anmeda, Astakenis for their invaluable contributions and commitment to advancing quality standards in the pharmaceutical industry.
Conclusion: Inspiring Change and Driving Transformation
As the curtains drew to a close on the 4th Annual Pharma GMP & Quality Management 2024, participants departed with a renewed sense of purpose and inspiration. The event catalysed meaningful discussions, fruitful collaborations, and actionable insights, paving the way for positive change and transformation in the pharma quality landscape.
Source: Press Release
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