Live webcast on US, EU and Japan GMP Requirements Practical ICH Area Differences, Healthcare...

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Page 1: Live webcast on US, EU and Japan GMP Requirements Practical ICH Area Differences, Healthcare Authority Inspection Focus By compliance2go

8/12/2019 Live webcast on US, EU and Japan GMP Requirements Practical ICH Area Differences, Healthcare Authority Inspection Focus By compliance2go

http://slidepdf.com/reader/full/live-webcast-on-us-eu-and-japan-gmp-requirements-practical-ich-area-differences 1/3

TUESDAY APRIL-29-2014   01:00 PM | 02:30 PM – EST DURATION: 90 MINUTES

Live webinar on "US, EU and Japan GMP Requirements: Practical

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Page 2: Live webcast on US, EU and Japan GMP Requirements Practical ICH Area Differences, Healthcare Authority Inspection Focus By compliance2go

8/12/2019 Live webcast on US, EU and Japan GMP Requirements Practical ICH Area Differences, Healthcare Authority Inspection Focus By compliance2go

http://slidepdf.com/reader/full/live-webcast-on-us-eu-and-japan-gmp-requirements-practical-ich-area-differences 2/3

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8/12/2019 Live webcast on US, EU and Japan GMP Requirements Practical ICH Area Differences, Healthcare Authority Inspection Focus By compliance2go

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Live 

$189One Dial In - OneAttendee

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CA S"ssi*n #i!h !h" E;("&! !* %s8 )*& "s!i*n

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For any assistance contact us at [email protected]  or call us

at 877.782.4696 Or Visit us:- h!!(s:CC###.*m('i%n"2+*.*mC(&*,!CG

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