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cGMPWhy does it matter to me?
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Quick Intro to RK and KC
Rebecca Klopp
Super awesome lo ic
Karen Chien
! yrs in Med "e#ices$ead %uditor CertPast& Internal %uditand C%P% 'ocus()*iotech&"e#iations and *atchRe#iew + ,eri-cationPhilosophy& Grandma
.est
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What do each o' the 'ollowinstand 'or?
cGMP/?
C0R/?
0"%/?
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1ow?
Protect public health0"%/what do they do?
*y assurin sa'ety2 e3cacy2 and security o'dru s2 products2 de#ices2 and 'ood
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.oday we will learn&
% little 0"%4GMP history lesson/ 56
e#ents rele#ant to us2 today at)*iotech7
.he rules and where to -nd them
.he conse8uences o' non9compliance
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Since :;;6 .he Industrial Revolution brou hthu e chan e to a riculture2manu'acturin 2 marketin 2 anddeli#ery o' 'ood and products