Modernizing Medicine - How Pharma is Manufacturing the Future

Pharmaceutical manufacturing is undergoing a transformation—driven by new treatments, evolving regulatory expectations, and the need for speed without compromising quality. At the 2025 Fall Conference, the PDA Southeast Chatper will bring together industry leaders and technical experts to explore how pharma is modernizing its approach to facility design, commissioning, validation, and aseptic assurance.

This year’s theme, Modernizing Medicine – How Pharma is Manufacturing the Future, highlights the critical role of manufacturing in enabling innovation. From the earliest stages of facility planning to the final steps of regulatory approval, this conference offers a practical roadmap for success in today’s complex landscape.

With three focused sessions, expert-led presentations, and networking during the breaks, this conference is designed for professionals who are driving innovation and operational excellence across the pharmaceutical manufacturing landscape.

Design and Cleanroom Considerations for Manufacturing Facilities – Peter Makowenskyi, G-CON Manufacturing

Safety Countercurrents: Leveraging Biorisk Management and Quality Synergies in CDMO Operations – AJ Troiano, Ph.D., FUJIFILM Lifesciences Biotechnologies

Starting a New Project: Where to Start and Where to Go – Michael DeHart, Ph.D., CMP Pharma

Commissioning and Release of Facilities/Equipment for Commercial Manufacturing – Jennifer Popovich, Catalent

Optimizing Strategic Communication to Drive Regulatory Compliance – Julia Kelb, Eli Lilly and Company

Advancing Aseptic Quality Assurance: Applying the ANSI-03 Quality Risk Management Standard – Noël Long, Cytiva

Glenn Wright, President/CEO, PDA

Peter Makowenskyi, Sr. Director, G-CON Manufacturing

AJ Troiano, Ph.D., Director, FUJIFILM Lifesciences

Michael DeHart, Ph.D., Director, CMP Pharma

Jennifer Popovich, Director, Catalent

Julia Kelb, Senior Associate, Eli Lilly

Noël Long, Senior Adviser, Cytiva

• The State View Hotel – 2451 Alumni Dr, Raleigh, NC
• Aloft Raleigh – 2100 Hillsborough St, Raleigh, NC

$150 PDA Member

$175 PDA Non-member

$25 Students (must present valid student ID at check-in)

$750 Exhibitor Pass, includes booth space + 1 registration pass

Host or Publisher PDA Southeast Chapter