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    Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations

    View: 145

    Website | Edit Freely

    Category Electronic document system, Functional, QA managers, Lean Project

    Deadline: February 06, 2020 | Date: February 06, 2020

    Venue/Country: Online Webinar, U.S.A

    Updated: 2020-01-04 18:20:22 (GMT+9)

    Call For Papers - CFP


    Inadequate investigation of out-of-specification (OOS) results in the laboratory is a common observation cited in FDA 483s and Warning Letters. It is clear that regulatory investigators throughout the world are looking at laboratory operations very closely.

    This Live Webinar Will Cover:

    -The requirements for laboratory OOS investigations.

    -Latest Regulatory expectations.

    -The laboratory OOS investigation process.

    -Laboratory investigation, Phase I.

    -Laboratory investigation, Phase II.



    -Communicating with Quality Assurance.


    John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan

    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.