PDA Southeast Chapter

2 More days - Oct 11th - to submit a nomination for the PDA Southeast Chapter 2025-27 open Board Member positions.

🍂 PDA Southeast Chapter Fall Conference Agenda "From Discovery to Delivery is Out 🍁 Agenda:   08:00am - 09:00am | Registration/Breakfast   09:00am - 10:00am | Opening Session: From Discovery to Delivery: Transforming Breakthroughs into Lifesaving Solutions 09:00am - 09:05am | Welcome Remarks from PDA Southeast Chapter President Austin Caudle, Sr Account Exe., Redica 09:05am - 09:15am | What can PDA do for you? David Talmage, VP, Education, PDA - Parenteral Drug Association & Jared Wine, PDA Southeast Chapter Member-At-Large/Student Liaison & Mgr, 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 Lab 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 Inc. 11:30am - 11:45am | Q&A   11:45am – 1:00pm | Lunch Tech Talks provided by Ecolab, FUJIFILM Wako Chemicals USA, Innerspace - The Simulator Company, Kymanox   1:00pm - 2:45pm | Session 2: Phase Appropriate Application of CGMP 1:00pm – 1:30pm | Phase Appropriate Application of CGMP *PENDING APPROVAL* LT Seneca Toms, MS, RAC, MSEH, National Expert, Pharmaceuticals, FDA Office of Regulatory Affairs (ORA) Pharmaceutical Quality Programs Branch (PQPB) 1:30pm - 2:00pm | Quality by Design in mRNA Therapeutics Irina Tcherepanova Ph.D., Independent Consultant 2:00pm - 2:30pm | Case Studies on the Application of GMPs for Clinical Stage Biopharmaceutical Companies Brittany Bell, ASQ-CQA, Mgr, Manufacturing Quality, Kymanox, Caitlin Kinard, Sr 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, ASQ FELLOW, Dir of Toxicology & Quality Services, PharmEng Technology 3:45pm - 4:15pm | Biopharmaceutical Design Transfer Case Study to Support Cleaning Validation Lifecycle, Paul Lopolito, Dir, 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 - 4:55pm | Panel Discussion Panelists: Seneca Toms, MS, RAC, MSEH, National Expert, Drugs, FDA Wendy Haines, PhD, DABT, ERT, ASQ CQA, ASQ FELLOW, Dir. of Toxicology & Quality Services, PharmEng Technology Virginia Boldt, Supply Chain Lead, Fusion Pharmaceuticals Brittany Bell, ASQ-CQA, Mgr, Manufacturing Quality, Kymanox Melody S., M.S., MBA, Dir Supply Chain, Amgen Kelli Collin, MBA Sr VP, Quality, Shattuck Labs 4:55pm - 5:00pm | Closeout of conference Casey Poirier, PDA Southeast Chapter President Elect, Account Mgr, Steris

🍂 PDA Southeast Chapter Fall Conference Agenda "From Discovery to Delivery is Out 🍁 Agenda:   08:00am - 09:00am | Registration/Breakfast   09:00am - 10:00am | Opening Session: From Discovery to Delivery: Transforming Breakthroughs into Lifesaving Solutions 09:00am - 09:05am | Welcome Remarks from PDA Southeast Chapter President Austin Caudle, Sr Account Exe., Redica 09:05am - 09:15am | What can PDA do for you? David Talmage, VP, Education, PDA - Parenteral Drug Association & Jared Wine, PDA Southeast Chapter Member-At-Large/Student Liaison & Mgr, 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 Lab 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 Inc. 11:30am - 11:45am | Q&A   11:45am – 1:00pm | Lunch Tech Talks provided by Ecolab, FUJIFILM Wako Chemicals USA, Innerspace - The Simulator Company, Kymanox   1:00pm - 2:45pm | Session 2: Phase Appropriate Application of CGMP 1:00pm – 1:30pm | Phase Appropriate Application of CGMP *PENDING APPROVAL* LT Seneca Toms, MS, RAC, MSEH, National Expert, Pharmaceuticals, FDA Office of Regulatory Affairs (ORA) Pharmaceutical Quality Programs Branch (PQPB) 1:30pm - 2:00pm | Quality by Design in mRNA Therapeutics Irina Tcherepanova Ph.D., Independent Consultant 2:00pm - 2:30pm | Case Studies on the Application of GMPs for Clinical Stage Biopharmaceutical Companies Brittany Bell, ASQ-CQA, Mgr, Manufacturing Quality, Kymanox, Caitlin Kinard, Sr 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, ASQ FELLOW, Dir of Toxicology & Quality Services, PharmEng Technology 3:45pm - 4:15pm | Biopharmaceutical Design Transfer Case Study to Support Cleaning Validation Lifecycle, Paul Lopolito, Dir, 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 - 4:55pm | Panel Discussion Panelists: Seneca Toms, MS, RAC, MSEH, National Expert, Drugs, FDA Wendy Haines, PhD, DABT, ERT, ASQ CQA, ASQ FELLOW, Dir. of Toxicology & Quality Services, PharmEng Technology Virginia Boldt, Supply Chain Lead, Fusion Pharmaceuticals Brittany Bell, ASQ-CQA, Mgr, Manufacturing Quality, Kymanox Melody S., M.S., MBA, Dir Supply Chain, Amgen Kelli Collin, MBA Sr VP, Quality, Shattuck Labs 4:55pm - 5:00pm | Closeout of conference Casey Poirier, PDA Southeast Chapter President Elect, Account Mgr, Steris  

Nominations for the 2025-2027 PDA Southeast Chapter Board are due Oct 11th - next Friday. If you live in KY, AL, FL, GA, MS, NC, SC, TN or Southern VA and enjoy discussing sterile drug development - please consider running. We could use your local presence on the Board and help the New Board represent the Southeast.

PDA Southeast Chapter sincerely thanks our 2024 Silver Sponsor – Quality CMC Consulting👏 Quality CMC Consulting, LLC is an award-winning pharmaceutical development consulting firm helping clients since 2012. The company provides global pharma, biotech, and medical device clients innovative solutions that are phase appropriate while applying a balanced interpretation of regulatory expectations and risk. This approach has helped numerous clients succeed in positioning their drug asset for regulatory approval (preIND to market application) and M&A deals. Quality CMC Consulting has worked with numerous drug product types (injectable, oral (liquid & solid), inhaled (solid/liquid), and topical) serving small start-ups to large pharma with a niche in outsourced drug development and novel therapies. Services provided are in Quality Control, CMC Regulatory, Technical Operations, and Quality Assurance. For More Information, go to https://lnkd.in/eZyNbJj8 or contact info@qualitycmcconsulting.com #thankfulthursday PDA - Parenteral Drug Association

Come on out next Tuesday (October 1st) for Trivia night at Boxyard RTP! Join fellow industry nerds and see if your collection of random facts is worthy of praise or scorn! The fall weather is glorious in RTP, so don't be shy. See you then! https://lnkd.in/ewBpQdXN

📣 Want to advance your career and give back to the PDA - Parenteral Drug Association community? Now is your chance to get more involved with our, PDA Southeast Chapter. Take advantage of our open leadership opportunities and contribute to our Chapter's growth and success. Volunteering your time and expertise is crucial to focus on specific initiatives, issues, and programs important to our industry and meeting the needs of our membership. Why this is a valuable opportunity for you: Serving as a PDA chapter officer is the perfect opportunity to grow your network, learn new technical and practical skills, and serve the local pharma community through organizing educational and social events. We are currently seeking nominees for the 2025-2027 Chapter Officers. If you know someone interested in serving as an officer or want to nominate yourself, please contact Adonna Cox (chapters@pda.org) by 11 October.  Elections will be held in November, and all newly-elected officers will assume their responsibilities in January 2025. The positions available to be filled are: - President (Non-elected) - President-Elect - Secretary - Treasurer - Member At Large To learn more about each role, please read the Chapter Officer Role Descriptions to see which best fits your skills: https://lnkd.in/e8NY2CWR We encourage you to consider serving as a chapter officer or volunteer. If interested, please reply by 11 October 2024 to discuss the next steps. If you have any questions, please get in touch with Adonna Cox (chapters@pda.org) 🙏 Thank you to the current PDA Southeast Chapter Board Members that have been volunteering.

The PDA Southeast Chapter is excited to invite you to our Fall Conference, highlighting challenges and opportunities "From Discovery to Delivery" of a drug product. Join industry experts as they share the latest advancements in pharmaceutical sciences. This conference is a unique opportunity to engage with thought leaders, explore cutting-edge technologies, and network with professionals dedicated to transforming the future of our industry. Don't miss your chance to be part of this dynamic event shaping the future of pharmaceuticals! Tickets are available starting 27AUG2024 at the following link: https://lnkd.in/e9fce99a Early bird pricing is available until 10SEP2024. See you there!

The PDA Southeast Chapter is excited to invite you to our Fall Conference, highlighting challenges and opportunities "From Discovery to Delivery" of a drug product. Join industry experts as they share the latest advancements in pharmaceutical sciences. This conference is a unique opportunity to engage with thought leaders, explore cutting-edge technologies, and network with professionals dedicated to transforming the future of our industry. Don't miss your chance to be part of this dynamic event shaping the future of pharmaceuticals! Tickets are available starting 27AUG2024 at the following link: https://lnkd.in/e9fce99a Early bird pricing is available until 10SEP2024. See you there!