PDA Southeast Chapter: Fall Conference

Durham, NC
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We extend our warm invitation to the PDA Southeast 2023 Fall Conference, scheduled for October 25, 2023 at Apella by Alexandria in Durham, NC. The conference promises to be an unforgettable experience, and we are thrilled to have handpicked the most distinguished and respected industry experts to share their insights and knowledge on the latest industry trends.

Attending the conference is an excellent opportunity to network with some of the industry's top professionals, as well as friends and colleagues. As seats are limited, we highly encourage you to secure your spot as soon as possible.

We look forward to seeing you at our highly anticipated fall event!

Event Location
12 Davis Drive, Durham, NC Get Directions

Contact

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

Standard Pricing

Standard Member Price

$50

Day 1

  • 07:00 - 8:00 | Vendor Arrival and Set-up
  • 08:00 – 09:00 | Registration – Lobby sign-in table sponsored by Arcadis DPS Group
    • Breakfast Networking Session Sponsored by ValSource
  • 09:00 – 10:30 | Opening Session: Connecting People, Science and Regulation

    • Moderator: Austin Caudle, Senior Account Executive, Redica Systems

    We open our annual event with a focus on the PDA motto: Connecting People, Science, and Regulation. Ms. Seymour will give us insight into her journey from “batch record reviewer” to Chief Quality Officer. Tita Tavares will provide the highlights from the PDA student GPS program, and we will hear from PharmD candidate Julia Geith. The PDA SE chapter sponsored Ms. Geith to attend the PDA Pharmaceutical Microbiology conference in October 2023; she will give us insight into her experience at a national PDA event.

  • 09:00 – 09:10 | Welcome Remarks from PDA SE President (10 min)
    • Austin Caudle, Enterprise Business Development, Redica Systems
  • 09:10 – 09:40 | Title of Presentation (TBD) (30 min)
    • Melissa Seymour MBA, Chief Quality Officer, Bristol Myers Squibb
  • 09:40 – 10:00 | PDA Student GPS/Nexus (20 min)
    • Tita Tavares, Chief of Staff, PDA
  • 10:00 – 10:10 | Reflections on PDA Microbiology Conference as a Student (10 min)
    • Julia Geith, PharmD Candidate (2025), University of South Carolina, School of Pharmacy
  • 10:10 – 10:30 | Q&A (20 min)
  • 10:30 – 11:00 | Networking Break in the Exhibit Area – Sponsored by Lonza
  • 11:00 – 12:30 | Session 1: Advanced Quality Mindset
    • Moderator: Amanda McFarland, Senior Consultant, ValSource, Inc.

    This session will be centered around using new and novel quality approaches that enable sterility assurance and speed to patients.

  • 11:00 – 11:20 | USP <797>: Changes: What you need to know (20 min)
    • Melissa Stefko, Senior Director of Quality, The FlexPro Group, a Network Partners Company
  • 11:20 – 11:40| Application of Rules- Bases QRM Approach for Selection of  Number of PPQ Batches (20 min)
    • Mike Long, Ph.D, MBB, Senior Director, Process Engineering and Packaging, Biopharmaceutics Development, AstraZeneca 
  • 11:40 – 12:00| Title of Presentation (TBD) (20 min)
    • Peter Baker, Former FDA Investigator & President, Live Oak Quality Assurance
  • 12:00 – 12:20| Q&A (20 min)
  • 12:20 – 12:30 | Cambrex “Tech Talk”
  • 12:30 – 13:30 | Lunch
  • 13:30 – 15:00 | Session 2: State of the Southeastern US Pharma Industry
    • Moderator: Kim Sobien, Senior Consultant, ValSource, Inc.and Nathan Blazei, Head of Quality and Regulatory Affairs, Kymanox

    This session will explore the industry activities in the Southeast. Maria Thacker Goethe, President and CEO of Georgia Bio, will provide an overview of the elements that are driving businesses to the SE region. Our distinguished panel will answer your questions about the state of the SE industry, including: Where are the job opportunities? What is being put in place to drive new organizations toward our region? How do we develop and maintain a skilled workforce?

  • 13:30 – 13:50 | State of the Industry (20 min)
    • Maria Thacker Goethe, President and CEO, Georgia Bio
  • 13:50 – 14:50 | State of the Industry Panel Discussion / Q&A (60 min)

  • Melissa Seymour MDA, Chief Quality Officer, Bristol Myers Squibb
  • Maria Thacker Goethe, President and CEO, Georgia Bio
  • Janeen Skutnik-Wilkinson, Director, Global Quality & Regulatory Surveillance, Moderna
  • Dom Reigle, Director, GxP Quality Systems, SpringWorks Therapeutics
  • Laura Rowley, Vice President Life Science Economic Development, NC Bio
  • CED (Invited)
  • 14:50 – 15:00 | Millipore “Tech Talk”
    • 15:00 – 15:30 | Networking Break in the Exhibit Area Sponsored by Environmental Specialties
  • 15:30 – 17:30 | Session 3: Navigating Drug Shortages and Supply Chain Obstacles
    • Casey Porier, Formulated Chemistry & Sterility Assurance Products Account Manager, Steris

    Navigating drug shortages and supply chain obstacles takes skilled compliance professionals, innovation, and a solid commitment to our patients. In this session, Ms. Stefko will provide an overview of the USP <797> updates and the impact of the changes. Mr. Ames will challenge us to think beyond the status quo and leverage Artificial Intelligence tools to predict supply chain vulnerabilities. And Kara Renai King will take us to the front lines of disaster recovery.

  • 15:30 – 15:50 | AI and the Future of Supply Chain Risk Management (20 min)
    • Henry Ames, Director Global Life Sciences and Healthcare, Everstream Analytics
  • 15:50 – 16:20 | Title of Presentation (TBD) (30 min)
    • Lou Kennedy, Owner, Nephron Pharmaceuticals
  • 16:20 – 16:50 | Title of Presentation (TBD) (30 min)
    • Kara Renai King, VP and Site Head Rocky Mount, Pfizer 
  • 16:50 – 17:20| Q&A (30 min)
  • 17:20 | Closeout of Conference (10 min)
    • Casey Porier, Formulated Chemistry & Sterility Assurance Products Account Manager, Steris
Agenda is subject to change.

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.

12 Davis Drive
Durham, NC ,

Apella by Alexandria