PDA Southeast Chapter: 2024 Fall Conference

Raleigh, NC
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Join us at the highly anticipated PDA Southeast Chapter Fall Conference, where top experts in Life Sciences will converge to exchange groundbreaking ideas and delve into the critical path from drug discovery to delivery.

Don't miss this exclusive event at the Brier Creek Country Club. Your presence will make a difference!

Standard Registration

Member Price

$125.00 + $10.23 Fee

StudentMember Only

$25.00

Non-Member

$150.00 + $11.90 Fee

See Qualifying Criteria for Member Types.

Day 1

08:00am - 09:00am | Registration/Breakast

09:00am - 10:00am | Opening Session: From Discovery to Delivery: Transforming Breakthroughs into Lifesaving Solutions

09:00am - 09:05am | Welcome Remarks from PDA SE President Austin Caudle, Senior Account Executive, Redica

09:05am - 09:15am | What can PDA do for you? Mike Porter, Senior Director, Education, PDA, Jared Wine, PDA SE Chapter Member-At-Large/Student Liaison and Manager, Engineering, ValSource

09:15am - 09:45am | Getting a Drug from Bench to Bedside, Pepper Landson, CPC, Co-Founder & CEO, Pratego, Inc.

09:45am - 10:00am | Q&A

10:00am - 10:30am | Networking Break

10:30am - 11:45pm | Session 1: Technical Outsourcing: CDMO and Contract Relationships

10:30am - 11:00am | Lessons Learned on Navigating the CDMO-Sponsor Partnership, Virginia Boldt, Supply Chain Lead, Fusion Pharmaceuticals

11:00am - 11:30am | Sponsor CDMO Relationships Managing Expectations Post Covid, Angelica Welch, MSAT Consultant, ValSource

11:30am - 11:45am | Q&A

11:45am - 1:00pm | Lunch: Tech Talks provided by Ecolab, Fujifilm Wako Chemicals, Innerspace GmbH, Kymanox

1:00pm - 2:45pm | Session 2: Phase Appropriate Application of CGMP

1:00pm - 1:30pm | Phase Appropriate Application of CGMP, LT Seneca Toms, MS, RAC, MSEH, National Expert, Pharmaceuticals, FDA Office of Regulatory Affairs (ORA) Pharmaceutical Quality Programs Branch (PQPB)

1:00pm - 1:30pm | Quality by Design in mRNA Therapeutics, Irina Tcherepanova Ph.D., Independent Consultant

2:00pm - 2:30pm | Phase Appropriate QMS and GMP Evolution- Clinic to Commercial, Brittany Bell, ASQ-CQA, Manager, Manufacturing Quality, Kymanox, Caitlin Kinard, Senior Quality Specialist, Kymanox

2:30pm - 2:45pm | Q&A

2:45pm - 3:15pm | Networking Break

3:15pm - 4:30pm | Session 3: Preventing Cross-Contamination in Process Cleaning

3:15pm - 3:45pm | Overview of Extractables & Leachables, Wendy Haines, PhD, DABT, ERT, ASQ CQA, Director of Toxicology & Quality Services, PharmEng Technology

3:45pm - 4:15pm | Biopharmaceutical Design Transfer Case Study to Support Cleaning Validation Lifecycle, Paul Lopolito, Director, Technical Services, STERIS

4:15pm - 4:30pm | Q&A

4:30pm - 5:00pm | Session 4: Panel Discussion – The Journey from Molecule to Market

4:30pm - 5:00pm | Panel Discussion

  • LT Seneca Toms, MS, RAC, MSEH, National Expert, Drugs, FDA
  • Wendy Haines, PhD, DABT, ERT, ASQ CQA, Director of Toxicology & Quality Services, PharmEng Technology
  • Virginia Boldt, Supply Chain Lead, Fusion Pharmaceuticals
  • Brittany Bell, ASQ-CQA, Manager, Manufacturing Quality at Kymanox
  • Melody Scott, M.S., MBA, Director Supply Chain, Amgen North Carolina
  • Kelli Collin, Senior Vice President, Quality, Shattuck Labs

4:55pm - 5:00pm | Closeout of conference Casey Porier, PDA SE President Elect, Account Manager, STERIS

Agenda is subject to change.

Featured Presenters

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.

Hotel Options

Courtyard Raleigh-Durham Airport/Brier Creek, 10600 Little Brier Creek Ln, Raleigh, NC 27617

Courtyard Raleigh-Durham Airport

 

Embassy Suites by Hilton Raleigh Durham Airport Brier Creek, 8001 Arco Corporate Dr, Raleigh, NC 27617

Embassy Suites by Hilton