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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