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March 5, 2024, Hyderabad, India – PQE Group is pleased to announce its participation in the upcoming 2024 PDA India Chapter Annual Meeting and Workshop, which will focus on current, critical topics in the pharmaceutical and medical device industries in India. This important conference will be held March 11-15 in Hyderabad, India.
Topics of discussion will focus on environmental monitoring, aseptic processing, and inspection trends on cleaning validation/cross contamination issues and findings, as well as compliance and remediation issues in the pharmaceutical and medical device arenas. Regulatory inspectors and compliance decision makers, along with industry subject matter experts, will share their innovative ideas and knowledge of current technologies, data integrity, internal audits and aseptic line design in addition to other critical topics that support quality in pharmaceutical and medical device products.
On the first day of the conference, the opening plenary sessions will feature opening remarks from Dr. Sarah McMullen, Country Director, US FDA India Office, Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, ORA/FDA, Dr. Anil Sawant, Senior Vice President, Global Quality Compliance, Merck Sharpe & Dohme, USA and Chair, Board of Directors, PDA Inc, a Regulatory Update will be provided by Dr. Carmelo Rosa, Director Division of Drug Quality I, CDER/OMQ/US FDA and Co-Chair, PDA India Chapter and many other exciting regulatory presenters. Annual Meeting Day One will also focus on Quality Culture, with sessions including topics regarding several aspects of the importance of Quality Culture, Quality Sustainability, and Quality Maturity, which will be led by presenters including Dr. Rosa, Dr. G.K. Raju, Chairman and CEO, Light Pharma Inc., Stephen Tyrpak, Vice President of Operations, PQE Group, and Dr. Deva Puranam, Head – Global Quality Investigations, Surveillance & Regulatory Communications, Viatris.
On March 14-15, a “Back to Basics” workshop led by the US FDA and industry experts will feature open discussions on important guidance documents and regulations. The purpose of this workshop is to share the regulatory expectations that will allow conference participants to understand how to operate and remain in a sustainable state of control.
PQE Group is a proud supporter of the PDA India Chapter Annual Meeting and exhibiting. Please stop by booth #7 to learn more about PQE’s capabilities. In addition, Stephen Tyrpak, PQE Group Vice President of Operations, will present at several sessions, speaking on topics including Quality Culture, Managing Quality and Risk across the Entire Combination Product Lifecycle, and Visual Inspections, in which he will present case studies and a hands-on demonstration. In addition to numerous other industry experts, FDA Regulators from the US and the European Directorate for Quality of Medicines (EDQM) will present and lead sessions throughout this conference.
“PQE Group is delighted to participate in, present at, and support the PDA India Chapter Annual Meeting, which has grown considerably over recent years and which provides extraordinarily valuable lessons and critical information to the pharmaceutical and medical device industry members working in and on behalf of India,” said Mahesh Jagtap, PQE Group’s local partner in India. “Since the inception of PQE Group in India in 2019, we have grown substantially, and currently we have more than 110 skilled resources spread across India serving compliance needs of Indian and South Asian pharma and medical device companies. We are also pleased that several PQE Group executives, including Founder & CEO Gilda D’Incerti, Vice President Executive Danilo Neri, and Vice President Thomas Carganico, will be in attendance throughout the conference. We hope to see many of our friends and associates at this great event, and to make many new connections, all of whom we invite to visit us at exhibit booth #7 in the Exhibit Hall. We look forward to a fruitful, highly informative and educational week in Hyderabad.”
About PQE Group
With over 2,000 employees, PQE Group is a woman-owned leading Life Science consulting firm, providing high-quality solutions in GCP, GLP, GMP, and GDP areas to both industry giants and SMEs worldwide. With a focus on innovation, efficiency, and sustainability and with a global presence through its numerous offices located around the world, PQE Group continues to set industry benchmarks and drive positive change in the Life Science sector. The Group’s CEO & Founder, Gilda D’Incerti, has recently launched ReSQ-UP, a groundbreaking initiative in the Clinical Research Organizations field, focusing on supporting emerging startups in women’s health (FemTech), medical devices, and innovations in the medical cannabis sector.
PQE US: https://www2.pqegroup.com/us/
PQE India: https://www2.pqegroup.com/in/
Media Contact: Debra Kaufmann – d.kaufmann@pqegroup.com; +1.240.704.0550
