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    Webinar on Transfer of Analytical Methods and Procedures according to USP 1224

    View: 1807

    Website | Edit Freely

    Category Healthcare & Safety

    Deadline: July 21, 2106 | Date: July 21, 2106

    Venue/Country: Online, Canada

    Updated: 2016-06-30 18:40:15 (GMT+9)

    Call For Papers - CFP

    Description :

    When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter . Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new draft guidance from 2015 on validation of analytical methods. This seminar will give a good understanding of USP and FDA requirements and provide recommendations and tools for effective implementation.

    For easy implementation, attendees will receive

    SOP: Transfer of Analytical Methods

    Checklist: Transfer of Analytical Methods and Procedures

    Master Plan template and examples: Transfer of Analytical Methods and procedures

    Areas Covered in the Session :

    FDA and International expectations for method transfer

    Examples of FDA warning letters and how to avoid them

    The FDA Guidance on method transfer.

    The USP chapter : history, status, future

    Four approaches for analytical method transfer and testing

    Responsibilities of the transferring and receiving laboratory

    Developing a transfer plan and a pre-approval protocol

    Conducting comparative studies

    Criteria and approaches for risk based testing: what, when, how much?

    The importance and selection of acceptance criteria

    Dealing with technology transfer: validation requirements, regulatory notification.

    Method transfer from standard HPLC to UHPLC

    Most likely failures during method transfer

    Handling deviations from documented acceptance criteria

    Criteria for transfer waiver (omission of formal transfer)

    Method transfer protocol and summary report

    Who Will Benefit:

    Lab Supervisors and Managers

    QA Managers and Personnel


    Research & Development in Pharmaceutical Industry

    Pharmaceutical Quality Control

    Contract Laboratories




    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.