{"id":6295,"date":"2025-05-13T07:30:53","date_gmt":"2025-05-13T07:30:53","guid":{"rendered":"https:\/\/regtechafrica.com\/healthcare\/?p=6295"},"modified":"2025-05-29T11:35:51","modified_gmt":"2025-05-29T11:35:51","slug":"pharma-quality-reimagined-highlights-from-the-5th-annual-pharma-gmp-quality-management-2025","status":"publish","type":"post","link":"https:\/\/regtechafrica.com\/healthcare\/pharma-quality-reimagined-highlights-from-the-5th-annual-pharma-gmp-quality-management-2025\/","title":{"rendered":"Pharma Quality Reimagined: Highlights from the 5th Annual Pharma GMP &#038; Quality Management 2025"},"content":{"rendered":"<p>The pharma world came together once again at <b>The Westin Mumbai Garden City<\/b> on <b>April 24th &#8211; 25th, 2025<\/b>, for the highly anticipated <b>5th Annual Pharma GMP &amp; Quality Management 2025<\/b>, 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.<\/p>\n<p>From insightful keynotes to lively workshops and deep-dive panels, the event lived up to its promise: <b>&#8220;Empowering the Pharma Industry for Tomorrow.&#8221;<\/b><\/p>\n<p><b>Ms. Guneet Kaur Hayer<\/b>, 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.<\/p>\n<h3><b>Key Themes and Memorable Conversations<\/b><\/h3>\n<p>The first morning took off with <b>Dr. Damodharan M<\/b> 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&#8217;s audits, but for a future driven by sustainability and technological integration.<\/p>\n<p>Immediately after, <b>Aditya Chaudhary<\/b> 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.<\/p>\n<h3><b>Learning by Doing: Workshops that Engaged<\/b><\/h3>\n<p>The conference shifted gears into practical learning with <b>Ken Shitamoto<\/b> 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.<\/p>\n<p>Building on this, <b>Digambar Nigade<\/b> 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.<\/p>\n<p>Meanwhile, leaders from Veeva Systems, <b>Varadarajan Srinivasan<\/b> and <b>Pradeep Nagisetty<\/b>, 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.<\/p>\n<h3><b>Real-World Insights: Risk Management and Deviation Handling<\/b><\/h3>\n<p><b>Dr. Udaykumar Rakibe<\/b> (Pharma Mantra) took a practical approach to <b>Quality Risk Management<\/b>, using live case studies to demonstrate how frameworks like FMEA and HACCP should be applied across pharma processes.<\/p>\n<p>In a hands-on workshop, <b>Prashanth GN<\/b> 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.<\/p>\n<p>As the day wrapped up, <b>Ranjit Barshikar<\/b> (CEO, ObD International) delivered an impassioned session on building a <b>culture of quality<\/b> by strengthening internal teams through structured training and skill-gap assessments.<\/p>\n<h3><b>Day 2: The Future Beckons \u2014 Smart Labs, Gen AI, and Cyber Resilience<\/b><\/h3>\n<p>Day 2 opened with a fascinating live case study from <b>Dr. Amjad Basha<\/b> (Dr. Reddy\u2019s Labs) on <b>smart lab transformation<\/b>. His real-world example of digitizing R&amp;D environments offered practical lessons on overcoming adoption challenges.<\/p>\n<p>The technology thread continued with a high-energy panel led by <b>Archimedis Digital<\/b>&#8216;s leadership team starting with <b>Duraisamy Rajan Palani<\/b>, <b>Anand Govindarajan<\/b>, and <b>Jeyashri Thivari<\/b><span class=\"Apple-converted-space\">\u00a0 <\/span>exploring how <b>AI, digital twins<\/b>, and <b>augmented reality<\/b> are revolutionizing quality assurance and compliance.<\/p>\n<p>A pivotal moment arrived with the star-studded panel featuring <b>Ken Shitamoto<\/b>, <b>Abhijit S. Kulkarni<\/b> (Lupin Limited), <b>Shirish Ambulgekar<\/b> (Alkem Laboratories), and <b>Amit Malviya<\/b> (Zest Pharma). They passionately debated how <b>Gen AI<\/b> is transforming the pharma workforce, operational efficiency, and supplier management, while cautioning about responsible adoption.<\/p>\n<p><b>AV Jayakumar<\/b> from Ajanta Pharma shifted the spotlight onto <b>contamination control<\/b>, detailing how companies can align with the revised <b>EU GMP Annex 1<\/b> by building robust Contamination Control Strategies (CCS) based on risk assessment and facility design principles.<\/p>\n<p>In a refreshing break from technical discussions, the audience participated in the <b>#EminenceDigitalDetox<\/b> session. A unique wellness initiative by Eminence Business Media aimed at boosting mental agility and resilience in high-pressure GMP environments.<\/p>\n<p>Closing the day was a critical conversation on cybersecurity. <b>Guneet Kaur Hayer<\/b>, along with leaders like <b>Dr. A.R.M. Rao<\/b> (Aurobindo Pharma), <b>Chitti Babu<\/b> (Aurobindo Pharma), <b>Sanjeev Mahajan<\/b> (Innova Captab), and <b>Pushkar Lakhekar<\/b> (Cohance Lifesciences), outlined best practices for building cyber-resilient Quality Management Systems in an increasingly digitalized pharma world.<\/p>\n<h3><b>Acknowledgments: Celebrating Partnerships and Collaborations<\/b><\/h3>\n<p>Eminence Group extends heartfelt gratitude to all event partners whose support made this conference possible:<\/p>\n<ul>\n<li><b>Gold Partner<\/b>: <b>Veeva Systems<\/b><\/li>\n<li><b>Digital Transformation Partner<\/b>: <b>Archimedis Digital<\/b><\/li>\n<li><b>Silver Partner<\/b>: <b>Hexagon ETQ<\/b><\/li>\n<li><b>Exhibit Partners<\/b>: <b>Arcolab<\/b>, <b>Astakenis<\/b>, <b>Mactus Automation Pvt. Ltd.<\/b>, <b>SEEK<\/b> and <b>AmpleLogic<\/b><\/li>\n<\/ul>\n<p>Their contribution not only fuelled the event&#8217;s success but also underscored the collaborative spirit needed to transform pharma&#8217;s future.<\/p>\n<h3><b>Moving Forward Together<\/b><\/h3>\n<p>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.<\/p>\n<p>The Eminence Group thanks all participants, speakers, and partners for making the 5th Annual Pharma GMP &amp; Quality Management 2025 a resounding success and looks forward to an even more transformative 6th edition in 2026!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The pharma world came together once again at The Westin Mumbai Garden City on April 24th &#8211; 25th, 2025, for the highly anticipated 5th Annual Pharma GMP &amp; Quality Management&hellip;<\/p>\n","protected":false},"author":1,"featured_media":6297,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[107],"tags":[],"class_list":["post-6295","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sponsored-post"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/regtechafrica.com\/healthcare\/wp-content\/uploads\/2025\/05\/Pharma-Quality-Reimagined-Highlights-from-the-5th-Annual-Pharma-GMP-Quality-Management-2025.jpeg?fit=900%2C600&ssl=1","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/6295","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/comments?post=6295"}],"version-history":[{"count":1,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/6295\/revisions"}],"predecessor-version":[{"id":6298,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/posts\/6295\/revisions\/6298"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/media\/6297"}],"wp:attachment":[{"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/media?parent=6295"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/categories?post=6295"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regtechafrica.com\/healthcare\/wp-json\/wp\/v2\/tags?post=6295"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}