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Parenteral Drug Association Connecting People, Science and Regulation ®

PDA Delaware Valley Chapter Combination Products Workshop

Mar 26 - Mar 26, 2019 |
Mar 26, 2019 |
West Pharmaceutical Services | Exton, PA
  • Chapter
  • Western Hemisphere Events
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Please contact the PDA Delaware Valley Chapter, If you have any questions about this event.

  • 8:00 a.m. – 8:30 a.m. Registration
  • 8:30 a.m. – 8:55 a.m. Coffee and Continental Breakfast
  • 8:55 a.m. – 9:00 a.m. Opening Remarks
  • 9:00 a.m. – 9:45 a.m. Drug/Biologic PMOA perspective -
    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
  • 11:15 a.m. – 11:30 a.m. Fill/Finish Points to Ponder
  • 11:30 a.m. – 11:45 a.m. Analytical Testing Points to Consider
  • 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
  • 1:15 p.m. – 2:30 p.m. West Pharmaceutical Training Tour Group #1
    B&S Flex Filler – How to fill a Prefilled syringe system
    Analytical labs – Performance & CCI  testing-Considerations and equipment
  • 2:30 p.m. -3:30 p.m. West Pharmaceutical Training Tour Group #2
    B&S Flex Filler – How to fill a Prefilled syringe system
    Analytical labs – Performance & CCI  testing-Considerations and equipment
  • 3:30 p.m. Closing Remarks
Save the date for this event; more information will be coming soon.

This event wil be held at West Pharmaceutical Services, located at:
530 Herman O. W Dr,
Exton, PA 19341

Save the date for this event; more information will be coming soon.
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