ISPE-CaSA 2019 Education Seminar Series/WIP&YP Event & ToysforTots- RTP - December 3, 2019

    Event Date
    Add to Calendar ISPE-CaSA 2019 Education Seminar Series/WIP&YP Event & ToysforTots- RTP - December 3, 2019 ISPE-CaSA closes out 2019 with an automation forum hosted by Seqirus along with a Women in Pharma and Young Professionals mentoring event and Toys for Tots drive.  Topics include: Fill Finish Project/Equipment, Thomas Nash and Thomas Plante, Seqirus Seqirus is currently expanding their Fill Finish Manufacturing capacity with a new 90,000 sq. ft. facility in Holly Springs, NC.  The design of the new facility was done in coordination with Fluor and the construction (currently in progress) is being managed by BE&K.  The new facility will interface and integrate with the current Fill Finish manufacturing space.  This new facility has been sized to contain two (2) high speed Pre-Filled Syringe (PFS) Filling, Inspection, and Packaging lines.  Additional space has been designed for two (2) new Formulation suites, a new parts prep area, and new office and locker room areas for Manufacturing personnel.    Implementing an Enterprise Recipe Management System by Clay Schaeffer, Biogen The ISA/ANSI 88 standard for batch manufacturing has been in use for decades, however, in biopharma little progress has been seen in its adoption regarding the development and maintenance of product recipes.  Globalization of drug manufacturing, partnering strategies, and regulatory focus on data integrity are driving us to improve methods of managing product manufacturing knowledge.   This presentation gives an overview of Biogen’s early journey into Enterprise Recipe Management (ERM) to manage the transfer of knowledge from development into our manufacturing systems.      Justin Cook, PE, Technical Trainer with Sequence will lead a panel discussion following the presentations. Registration:                                                 1:30 - 2:00pm  Automation Presentations:                          2:00 - 5:00pm Networking Reception                                  5:30 - 7:30pm   $20 Non-Member, $15 Member, $10 Student/YP   REGISTER HERE for the Automation Forum  REGISTRATION ENDS 1PM Monday, Dec 2.  No walk-ins. The education will be followed by a networking  at the Carolina Brewing Company with a Toys for Tots campaign headed up by Women in Pharma and our Young Professionals.  To participate, please bring an unwrapped toy to the networking event.    The Carolina Brewing Company is one block away at 140 Thomas Mill Road. To participate in Toys for Tots: New, unwrapped toy Ages birth to 16 years old No realistic looking weapons No food items REGISTER HERE for Women in Pharma and Young Professionals event. Thank you to JacobsWyper our networking sponsor!   Seqirus 475 Green Oaks Parkway Holly Springs, NC 27540 United States rcisneros@rickzebradesigns.com America/New_York public
    Program Information

    ISPE-CaSA closes out 2019 with an automation forum hosted by Seqirus along with a Women in Pharma and Young Professionals mentoring event and Toys for Tots drive.

     Topics include:

    • Fill Finish Project/Equipment, Thomas Nash and Thomas Plante, Seqirus
      • Seqirus is currently expanding their Fill Finish Manufacturing capacity with a new 90,000 sq. ft. facility in Holly Springs, NC.  The design of the new facility was done in coordination with Fluor and the construction (currently in progress) is being managed by BE&K.  The new facility will interface and integrate with the current Fill Finish manufacturing space.  This new facility has been sized to contain two (2) high speed Pre-Filled Syringe (PFS) Filling, Inspection, and Packaging lines.  Additional space has been designed for two (2) new Formulation suites, a new parts prep area, and new office and locker room areas for Manufacturing personnel. 

    Thomas NashThomas Plante

     

    • Implementing an Enterprise Recipe Management System by Clay Schaeffer, Biogen
      • The ISA/ANSI 88 standard for batch manufacturing has been in use for decades, however, in biopharma little progress has been seen in its adoption regarding the development and maintenance of product recipes.  Globalization of drug manufacturing, partnering strategies, and regulatory focus on data integrity are driving us to improve methods of managing product manufacturing knowledge.   This presentation gives an overview of Biogen’s early journey into Enterprise Recipe Management (ERM) to manage the transfer of knowledge from development into our manufacturing systems.
    john schaeffer
    •      Justin Cook, PE, Technical Trainer with Sequence will lead a panel discussion following the presentations.

    Justin Cook

    Registration:                                                 1:30 - 2:00pm 

    Automation Presentations:                          2:00 - 5:00pm

    Networking Reception                                  5:30 - 7:30pm

     

    $20 Non-Member, $15 Member, $10 Student/YP

     

    REGISTER HERE for the Automation Forum  REGISTRATION ENDS 1PM Monday, Dec 2.  No walk-ins.

    The education will be followed by a networking  at the Carolina Brewing Company with a Toys for Tots campaign headed up by Women in Pharma and our Young Professionals.  To participate, please bring an unwrapped toy to the networking event.    The Carolina Brewing Company is one block away at 140 Thomas Mill Road.

    To participate in Toys for Tots:

    • New, unwrapped toy
    • Ages birth to 16 years old
    • No realistic looking weapons
    • No food items

    REGISTER HERE for Women in Pharma and Young Professionals event.

    Thank you to JacobsWyper our networking sponsor!

    JacobsWyper logo

     

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