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    Drug Substances and Drug Products - Specifications

    View: 126

    Website http://www.compliance4all.com/control/w_product/~product_id=501846LIVE?channel=ourglocal_May_2018_SE | Want to Edit it Edit Freely

    Category Drug Substances and Drug Products, Technical Operations, stability testing of drug substances and drug products, ich guidelines for stability studies, drug stability testing

    Deadline: May 22, 2018 | Date: May 23, 2018

    Venue/Country: Online, U.S.A

    Updated: 2018-03-20 15:01:21 (GMT+9)

    Call For Papers - CFP

    Overview:

    This program will teach you to set specificatons for drug substance and drug product,including use of release test data, long term stability, accelerated stability and special stability studies.

    Why should you Attend:

    Learn the recommendations of ICH for using testing and stability data to set specifications for drug substances and drug products including use of special stability studies. Learn requirements for changing specifiations through the lifestyle of the product.

    Areas Covered in the Session:

    Setting intial specifications

    How to use available data and justify spectifications

    ICH specific recommendations will be discussed

    Informaton required to br submitted during the lifecycle

    Who Will Benefit:

    Manufacturing

    Supply Chain

    Technical Operations

    Quality Control

    Quality Assurance

    Regulatory Affairs

    Speaker Profile:

    Peggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics.

    Event Fee: One Dial-in One Attendee Price: US$150.00

    Contact Detail:

    Compliance4All DBA NetZealous,

    Phone: +1-800-447-9407

    Email: supportatcompliance4All.com


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.