PDA Southeast Chapter: 2024 Fall Conference

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, Praetego, 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