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PDA Chapter

PDA Delaware Valley Chapter Combination Products Workshop

Mar 26, 2019
Exton, PA

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Overview

Please contact the PDA Delaware Valley Chapter, If you have any questions about this event.

Agenda

    • 8:00 a.m. – 8:30 a.m. Registration
    • 8:30 a.m. – 9:00 a.m. Breakfast and Opening Remarks
    • 9:00 a.m. – 9:45 a.m. Drug/Biologic PMOA perspective (components/del system/combination product)
      Presented by Suzette Roan, Sanofi
    • 9:45 a.m. – 10:30 a.m. Combination Products Risk Management and Control Strategies
      Presented by Susan Neadle, Leader, Value Chain Quality, Johnson & Johnson
    • 10:30 a.m. – 10:45 a.m. Break
    • 10:45 a.m. – 11:15 a.m. Combination Products Hot Topics; Post Approval Device Changes and the New EU MDR Article 117 Requirements 
      Presented by Doug Mead, Sr. Director, Regulatory Affairs, Johnson & Johnson
      and Preparation for Interactive Sessions
      Presented by Fran DeGrazio, VO, Scientific Affairs and Technical Services
    • 11:15 a.m. – 11:30 a.m. Flexible Filling for High Value Low Volume Products
      Presented by Simon Cote, Director, Technical Account, TCS, NA
    • 11:30 a.m. – 11:45 a.m. Considerations for Performance & CCI Testing and Technology
      Presented by Jennifer Riter, Sr. Director, Analytical Services
    • 11:45 a.m. – 12:30 p.m. Lunch break and Networking
    • 12:30 p.m. – 1:15 p.m. Panel Discussion and Q&A with all speakers
    • 1:15 p.m. – 1:30 p.m. Break into assigned groups
    • 1:30 p.m. - 3:30 p.m. Networking/ Expo / Fill Finish Demonstrations/Testing Demonstrations/Technical poster exhibit
    • 3:30 p.m. Closing Remarks

Travel

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.

West Pharmaceutical Services

530 Herman O. W Dr
Exton, PA

Directions

Registration Fees

Regular Price
Registration Type Price By 26 March
All PDA Members and PDA Non-Members $35

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