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    The document is a meeting agenda for a weekly meeting scheduled for December 8, 2006. The agenda includes 9 items to discuss, including ongoing issues with document downloading, the need for additional system documentation, updates to URS and CLIA documents, and schedules for releasing pending documents and SOPs. Responsible parties and target dates are assigned to address open items from previous meetings and new business.

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    MOM ALB

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    The document is a meeting agenda for a weekly meeting scheduled for December 8, 2006. The agenda includes 9 items to discuss, including ongoing issues with document downloading, the need for additional system documentation, updates to URS and CLIA documents, and schedules for releasing pending documents and SOPs. Responsible parties and target dates are assigned to address open items from previous meetings and new business.

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    © All Rights Reserved
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    5 views2 pages

    Mom Alb

    Uploaded by

    admissionsGNM NSN
    The document is a meeting agenda for a weekly meeting scheduled for December 8, 2006. The agenda includes 9 items to discuss, including ongoing issues with document downloading, the need for additional system documentation, updates to URS and CLIA documents, and schedules for releasing pending documents and SOPs. Responsible parties and target dates are assigned to address open items from previous meetings and new business.

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    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
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    of 2

    Meeting Agenda - Weekly Meeting

    Schedule for 08 Dec 2006

    December 7, 2006 Alfa Laval Biokinetics Inc.


    Michael S. Moglia 7 Penn Center
    1635 Market Street
    Suite 1500
    Philadelphia, PA 19103
    USA
    Tel +1 215-656-2500
    Fax +1 215-561-4444
    www.alfalaval.com

    Item # Item Topic of Discussion Responsibility Date


    Open / Discussion Items from Previous Meetings
    1 Citadon/Word Document opening Are problems still existing
    errors with downloading/Viewing
    Documentation from
    Citadon
    Problems still existing.
    Currently using work
    around – Comments being
    typed on separate word
    document and being
    uploaded to Citadon.
    2 Compressed Air Generation/Gas Documentation needed to
    Manifold Documentation/ AHU complete system
    Operations Manual Clean Steam documentation.
    Generation Manual Gas/Air Manifold
    Document/CS Generation
    Manual by 12th Dec
    3 URS Document Updates with Final release of URS
    operational set points and ranges documents required to
    complete system
    documentation.
    In the process, URS for
    Bioreactors shall be
    loaded onto Citadon by
    09th Dec 06. Documents
    shall be loaded based on
    the priority matrix.
    4 CLIA Revision 2 Documents Final CLIA documents
    needed to finalize DQ
    Documentation. Any Rev 2
    documents needs to be
    approved and updated in
    Citadon prior to DQ
    approval.
    In the process, CLIA for
    Bioreactors shall be
    loaded onto Citadon by
    09th Dec 06. Documents
    shall be loaded based on
    the priority matrix.

    Alfa Laval- Biokinetics


    Page 1 of 2
    Item # Item Topic of Discussion Responsibility Date
    5 Schedule for release of all pending URS Information needed to
    document which is in the ALB issue meaningful project
    scope schedule. Immediate
    Systems to be issued are
    the completion of the
    Buffer/Media Systems then
    Bioreactor and Harvest
    Systems (Final URS, CTP
    comments required for
    Bioreactor/Harvest)
    Remaining IOQ systems to
    be drafted without URS
    information.
    Buffer/Media Hold & Prep
    systems – URS Rev 2,
    CLIA Rev 2, URS_DQ Rev
    2.1, DQ Report Rev 1 –
    Approved copies shall be
    uploaded to Citadon
    today. CTP & IOQ for all
    14 systems have been
    uploaded to Citadon
    07.12.06
    6 SOP issue schedule for manual Buffer/Media O&M to be
    available (Loaded) released this week.
    Equipment/system CIP/SIP SOPs issued
    starting next week.
    7 Operation/Process Set Point and Comments included to CTP
    Ranges/URS documents are specific to CTP
    documents and may not
    include information required
    for IOQ.

    New Business
    8 CTP Comments Draft Document comments
    needed for CTP documents.
    Shall be loaded as per our
    priority list. Bioreactors
    related documents (URS
    Rev 2, CLIA Rev 2 & CTP)
    documents shall be
    loaded by 09.12.06
    9 All Other Business:

    Matrix of documents as per our priority shall be mailed today.

    Alfa Laval- Biokinetics


    Page 2 of 2

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