PDA Southeast Chapter: Fall Conference

Modernizing Medicine – How Pharma is Manufacturing the Future

30 Sep 2025
McKimmon Conference and Training Center at NC State University
Raleigh, NC

Educational Sessions, Networking Opportunities

Become a Sponsor and/or Exhibitor

Closed

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 th pharmaceutical manufacturing landscape.

Registration Options

$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

Agenda

Discover What's Happening Each Day
Tue 30 Sep
Tuesday, 30 September

08:00am - 09:00am | Registration/Light Breakfast

09:00am - 10:00am | Opening Session

09:00am - 09:05am | Welcome Remarks from PDA SE President 

09:05am - 09:15am | What can PDA do for you? Glenn Wright, President/CEO PDA

09:15am - 09:45am | Opening Speaker  

09:45am - 10:00am | Q&A

10:00am - 10:30am | Networking Break

10:30am - 11:45pm | Session 1 -Journey from Steel to Sterile

10:30am - 11:00am | Design and Cleanroom Considerations for Manufacturing Facilities-Peter Makowenskyj, Sr. Director of Design Consulting, G-CON Manufacturing

11:00am - 11:30am | Safety Countercurrents - Leveraging Biorisk Management and Quality Synergies in CDMO Operations, AJ Troiano, Ph.D., Director of Biosafety and Toxicology, FUJIFILM Lifesciences Biotechnologies

11:30am - 11:45am | Q&A

 11:45am - 12:45pm | Lunch  

12:45pm - 2:00pm | Session 2 -From Commissioning to FDA Approval

12:45pm - 1:15pm | Starting a New Project: Where to start and where to go, Michael DeHart, Ph.D. Director, Product Development, CMP Pharma 

1:15pm - 1:45pm | Commissioning and Release of Facilities/Equipment for Commercial Manufacturing, Jennifer Popovich, Director, Validation, Catalent 

1:45pm - 2:00pm | Q&A 

2:00pm - 2:30pm | Networking Break

2:30pm - 4:00pm | Session 3 – Standardizing Success

2:30pm - 3:00pm | Optimizing Strategic Communication to Drive Regulatory Compliance, Julia Kelb, Senior Associate – Quality External Engagement and Advocacy Communications and Value Realization, Eli Lilly and Company

3:00pm - 3:30pm | Advancing Aseptic Quality Assurance: Applying the ANSI-03 Quality Risk Management Standard, Noël Long, Senior Sterility Assurance Adviser, Cytiva

3:30pm - 3:45pm | Q&A

3:45pm - 4:00pm | Closeout of conference, PDE SE President-Elect 

Location and Travel

Venue Details and Accommodations

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

McKimmon Conference and Training Center at NC State University

1101 Gorman St
Raleigh, NC 27606
Reservation Instructions

Recommended Near by Hotels:

The State View Hotel- 2451 Alumni Dr. Raleigh, NC 27606

The Aloft- 2100 Hillsborough St. Raleigh, NC 27607

 

Registration

Pricing Options

Standard Registration

Member Price

$150

StudentMember Only

$25

Non-Member

$175

See Qualifying Criteria for Member Types.

Sponsor information will be available soon

We're currently finalizing our list of sponsors and will share the details shortly.

Become a Sponsor and/or Exhibitor

Amplify Your Presence and Reach Your Customers!
Become a Sponsor

Elevate your brand and maximize your exposure by becoming a sponsor at the PDA Southeast Chapter: Fall Conference! Connect with industry leaders, showcase your products and services, and establish your company as a key player in the field.

Request Information
Become an Exhibitor

Boost your brand and visibility by becoming an exhibitor at the PDA Southeast Chapter: Fall Conference! Connect with industry influencers, showcase your products and services, and position your company as a key player in the field.

Request Information
Contact Us
Have a question or need assistance?

Send us a message, and our team will get back to you shortly. We're here to help!

Contact

Chapter Inquiries
Tel: +1 (301) 656-5900

Membership Services