In light of COVID-19 (coronavirus) and our priority for the health and welfare of our members and staff, ASTM International has decided that it is inadvisable and impractical to hold the committee meetings in Prague on April 27-May 1. The decision was based on several factors, including, but not limited to:

    • Continued review of information and recommendations from the U.S. Centers for Disease Control and Prevention (CDC), the World Health Organization (WHO) and other governmental bodies.
    • Input from our members whose organizations are increasingly concerned with travel and the large gathering in Prague.
    • Watching the expanding trajectory of the coronavirus.

    Staff managers will be contacting committee leaders to plan alternatives for conducting committee business. For any committees that collected money for events, ASTM will work to issue refunds as necessary. Attendees are responsible for cancelling their own hotel reservations.

    Looking forward, we will rely on these and other relevant criteria and input points to assess the status of future scheduled ASTM meetings and events. Please consult our meeting webpage for the most up-to-date information. Thank you for your understanding and continued commitment to ASTM International.

    E55 Manufacture of Pharmaceutical and Biopharmaceutical Products

    Title: Workshop on Current and Future Standards Activities within Pharmaceutical and Biopharmacuetical Manufacturing

    Dates: Tuesday October 11 2016

    Location: FDA, White Oaks Campus; Silver Spring, MD

    Event Name: E55 October 2016 Meeting

    About The Event

    Registration Information

    Continuing Education Units

    Technical Chair Contact Information

    Standards Development Meetings

    Future Meeting Dates


    About the Event

    The Workshop on Current and Future Standards Activities within Pharmaceutical and Biopharmaceutical Manufacturing will be held Tuesday, October 11, 2016. Sponsored by ASTM Committee E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products and the FDA, the workshop will be held at the FDA’s White Oaks Campus in Silver Springs, MD, in conjunction with the October 2016 standards development meetings of the committee.

    Objective
    The propose of this workshop is to share the ASTM International Committee E55 on Pharmaceutical and Biopharmaceutical Manufacturing mission, the accomplishments of the group, the roadmap for the future of Committee E55, and to understand the FDA expectations about quality and operational standards. The workshop will have interactive sections with the participation of industry leaders and FDA representatives on four topics; viral filtration, data management, single use systems, and continuous manufacturing. The workshop will cover also FDA and Committee E55 perspectives on future standard work.

    Registration Information

    Online pre-registration will close September 30, 2016. The fees to attend this workshop are listed below. These fees include a boxed lunch for all non-FDA employees.

    B>FDA Employees – An FDA employee's fee will be waived provided that they can present a valid FDA ID badge upon check in at the workshop. The waived fee includes admission to the technical sessions only. Lunch will not be included for FDA employees.

    Students – A student's fee will be waived provided that they can present a valid student ID upon check in at the workshop. The waived fee includes admission to the technical sessions only. Lunch will not be included for students.

    All attendees, including presenters, ASTM members and FDA employees, are urged to register online for this event so that space requirements can be accommodated. If you do not register online by the closing date, then you must register upon arrival at the workshop. All attendees must check in at the ASTM registration desk upon arrival at workshop.

    Cancellation
    A refund of the workshop fee will be honored only if requested at least 10 business days prior to the workshop. To cancel your registration and request a refund, please contact Hannah Sparks at hsparks@astm.org or 610-832-9677.

    If you have questions concerning online registration, please contact Hannah Sparks in Symposia Operations at hsparks@astm.org, Tel: 610-832-9677, or ASTM Technical Support at support@astm.org or 1-877-909-2786 (domestic) or 610-832-9578 (international).

    Early Bird Regular Registration
    ASTM Member Fee50.0050.00
    Non-Member Fee60.0060.00
    Presenter FeeWaivedWaived
    Student FeeWaivedWaived

    Continuing Education Units

    Workshop attendees interested in receiving 0.70 Continuing Education Units (CEUs) should complete a CEU application form at the adjournment of the workshop, and then submit it to the ASTM staff member on site. A certificate will be sent to the attendee approximately 4 to 6 weeks after the workshop.


    Technical Chair Contact Information

    Additional information about the workshop is available from Workshop Chairman Pallavi Nithyanandan, FDA, email: Pallavi.Nithyanandan@fda.hhs.gov.


    Standards Development Meetings

    Meeting schedules of Committee E55 are posted on the ASTM web site at www.astm.org/COMMIT/COMMITTEE/E55.htm or contact the ASTM staff manager, Travis Murdock at tmurdock@astm.org. or tel: 610-832-9826.


    Future Meeting Dates

    Committee E55 invites you to attend their future standards development meetings. There is no fee to attend these meetings, and membership in ASTM International is not required. For more information, visit the web page listed immediately above, and click on "Future Meetings".


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