PDA INDIA CHAPTER ANNUAL MEETING 2025
Globalization, Modernization, Transformation
The 3rd Annual PDA India Chapter Meeting was held in the vibrant city of Hyderabad from 30 July to 1 August 2025 at the Novotel Convention Centre. Building on the overwhelming success of the previous sold-out editions, this year’s meeting was even more impactful – offering a robust platform to address critical industry issues and foster collaboration among professionals.
The 2025 PDA India Chapter Annual Meeting and Expo focused on the themes of globalization, modernization, and transformation in pharmaceutical manufacturing. The program brought together professionals from across the industry – ranging from young talent to senior executives in drug manufacturing, supply chain, devices and equipment, services, and global regulatory agencies.
Dr. Rustom Mody, Senior Vice President & Head R&D (Biologics), Sun Pharmaceutical Industries Ltd., and President of PDA India Chapter, welcomed attendees to the three-day event, highlighting the participation of leading global regulators and experts.
He extended special thanks to distinguished guests including Glenn Wright, President & CEO, PDA Inc.; Dr. Anil Sawant, Senior Vice President, Global Quality Transformation, Merck Sharp & Dohme, USA, and Chair, Board of Directors, PDA Inc.; Dr. Carmelo Rosa, Director, Division of International Drug Quality, US FDA; Constance L. Richard-Math, Senior Assistant Country Director, US FDA India Office; along with other dignitaries.
Founded in 2013, the PDA India Chapter supports the Indian pharmaceutical industry by connecting people, science, and regulations. Its mission is to foster knowledge sharing, develop expertise, and bridge the gap between industry needs and regulatory expectations. Dr. Mody stressed the importance of meaningful discussions to drive quality compliance improvements.
He noted that the record turnout at the 2025 Annual Meeting reflected the vibrant spirit of India’s pharmaceutical sector and the growing prominence of the PDA India Chapter, which has significantly expanded in size, scope, and influence through numerous meetings and workshops.
As a non-profit organization, PDA India channels earnings from such events into scientific education for industry and academia. The Chapter also provides PhD research fellowships to students from government-funded universities that have strong research programs but face funding shortages.
Dr. Mody encouraged attendees to actively participate, share experiences, and build relationships that would extend well beyond the conference. The gathering, he said, was a unique opportunity for global regulators and experts to work together on improving quality compliance and shaping the future of the pharmaceutical industry.
Critical Industry Topics
The three-day event featured a range of high-value sessions:
Day 1 – Inspection and Responses
The first day addressed the regulatory perspective on addressing inadequacies in inspection responses, covering trends and expectations. Speakers included Oisin Daly (GMP Inspector, EDQM), Ian Jackson (Expert GMP Inspector, MHRA), and Meera Kumari Ram Navas (Senior Principal Assistant Director, GMP Section, Centre of Compliance and Quality Control, NPRA).
Dr. Binh Nguyen (President, Wynngate Corporation) discussed leading inspection preparedness and enabling on-site inspections. Hemanth Panasa (Vice President, Centre of Excellence – Sterile Quality Operations, Cipla Ltd.) shared insights on the outcomes of self-inspections and internal audits.
Session 4 focused on investigation approaches and CAPA, featuring Ravi Chander Katta (Site Quality Director – Global Sterile Injectables, Pfizer Healthcare India Pvt. Ltd.), Raghuram Chandra Rao (AVP – Quality, Gland Pharma Ltd.), Milind Suryawanshi (General Manager – Vaccines Quality Audit, GSK), Dr. Carmelo Rosa (US FDA), Atul Agrawal (Division Director – Office of Inspections & Investigations, US FDA), Jose Melendez (Consumer Safety Officer, US FDA), and Eileen Liu (Consumer Safety Officer, US FDA).
Day 2 – Data Integrity and Quality Culture
The second day explored critical quality themes, beginning with a deep dive into Data Integrity, followed by a role-play session on human behaviour and error –examining why mistakes occur and how to prevent them. The day also covered cleaning validation and cleaning & disinfection from a regulatory perspective, highlighting common industry observations and inspection challenges.
Dr. Antony Gomas (Chief Quality Officer, Matrix Pharma Corp) opened with a talk on building the foundations of a quality system. Sessions on data integrity were led by Scott Deckebach (Executive Director, Lachman Consultant Services) and Vikram Shukla (President – Operations, Zydus Lifesciences Ltd.).
Speakers on human error included Abhay Kumar Shrivastava (President – Operations, Mankind Pharma), Vishal Sharma (Co-founder & Director, Vienni Training & Consulting LLP, and PDA India Board Member), Andrew Hopkins (Sr. Director of Compliance, Lachman Consultant Services), and Dr. Binh Nguyen.
Teaching methods and modes were presented by David Talmage (Vice President, PDA Inc.) and Dr. Marla Phillips (CEO & President, Pathway for Patient Health). Andrew Hopkins and Ian Jackson addressed cleaning guidance interpretation, while Jose Melendez presented inspection trends in cleaning validation. Lisa Flores and Guerlain Ulysse (Consumer Safety Officers, US FDA India) shared case studies on cleaning practices.
A joint session by Hopkins, Jackson, Melendez, Flores, and Ulysse discussed strategies for effective cleaning and disinfection across all organizational levels. The day ended with a panel discussion, Q&A, and closing remarks from Dr. Carmelo Rosa and Dr. Mody, followed by award announcements.
Day 3 – Lifecycle Approach to Risk Assessment in Sterile Product Manufacturing
The final day focused on comparing legacy installations and practices with newer systems. Presentations by Marcel Menhorn (Bausch+Ströbel), Frank Homberger (SKAN AG), Dirk Schuster (Groninger & Co.), and Gabriele Cassanelli (IMA Group) traced the evolution from open filling lines to isolator technology.
Dr. Anil Sawant spoke on building a quality culture and initiating transformation journeys, also presenting a PDA course on decision-making.
Session 12 featured discussions on legacy facilities, engineering excellence, designing smoke studies to identify risks in older systems, and safeguarding infrastructure. Speakers included Thomas J. Arista (Pharmaceutical Consultant, Ventana Novo LLC), Andrew Hopkins, and Raghuram Chandra Rao.
Arista also addressed identifying operational “traps” in daily work and innovative ways to overcome them. Other sessions covered regulatory expectations for airflow visualization studies (Lisa Flores & Guerlain Ulysse), open RABS systems (Eileen Liu), and the legacy of architectural frameworks – facilities, equipment, people, and procedures – presented by Krishna Venkatesh (Global Head – Quality & Pharmacovigilance, Dr. Reddy’s Laboratories) and Ranjit Menon (Site Director, Al-Shifa Pharma, Kuwait).
Panel Discussion
A key panel discussion focused on the implementation of digital technologies in manufacturing, emphasizing the importance of digital maturity assessments and team building. Key points included the establishment of a centre of excellence for AI and ML, the need for a clear roadmap and maturity assessment, and the integration of AI with legacy equipment.
Challenges such as cybersecurity, ROI measurement, and the cultural shift required for digital transformation were highlighted. The importance of continuous training and capability mapping across all levels of the organization was stressed, along with the need for a collaborative approach and top management commitment.
Panelists included Oisin Daly, GMP Inspector, EDQM; lan Jackson, Expert GMP Inspector, MHRA; Meera Kumari Ram Navas, Senior Principal Assistant Director, GMP Section, Centre of Compliance and Quality Control, NPRA; Binh Nguyen, President, Wynngate Corporation; and Hemanth Panasa, Vice President, Centre of Excellence, Sterile Quality Operations, Cipla Ltd. The session was moderated by Reem Malki, Chief Quality Officer, Sun Pharmaceutical Industries Ltd.
