lt

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(rdr Numbcororso* 1. ( r d d n u m b s o rP n G d P a e . 3 0 ' )

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'sdtar / .dubk aJru Nr' t, Dqb e.L lurd'w rw): lrutpt )LL
.'sutiar R cwt8 oJnrc. qq8tdv aryitg t0 uotu 4d (blgh$r'): dtcupt a\''a
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( 1 0x 2 = 2 0 )
L G'vevea s!on arswenj lo lhe rol@ings (2 nd ks ealh)
hai is Plafom lechnology)

harEcosco?
Assu6.ce-
eiineOuality

by Dosign(ObD).
DelineOuality

eiinelNestiqatio.alNew Druq(lND),
( 2 X 1 0= 2 0 )
l^alooyo- near by "Pior scaleup"?Disc-q^vsrioLspiol pLanl*are upcorsiderdlionlo'

Oiscuss
W.lOGuidellne on Transferot Technology
n Phama€uticalIndustry.
esclberolea.d irpoddre or GoodLaboralory oEc-li@s induslry.
(GLP):r prrar-a.eulical
( 7X 5 : 3 s )
e lh€approach oI QbDin quaiilymanagemenlsyslem.
nea sut.oLe on qJalilycollrolandarl/i.aLnelhod r€nsrer.
DGd,ssplalfoml."hnologywi'hrtsi'npo-lare.
DLscuss approvalprocedle ot new
dle a shodnoteon Oualitymanagehentsystem.
dlevariousfunctions
ofcDsco.
DiscusstheSUPACwilhvariouschangelevelsin b. ef.
-le d-hon noreonprarequisiles plal'o- lor -anyoevelopreI
loeslrbk5 a tpctao'ogv
Descbeclinical proto6l.
research
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ts@|id R .aABt ofrhz. cu5tia6 &nlinc t0 'noia e@hlt ,c l8wer, tuwt qnt rtro
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(2 m
C'vc!e^ ,honawets ro rhetollowinps rca(h
w*' 'h....I)mno{ &-c..doo, ro.mpr.,p ,,1* 'o p, otp - :
". "tett* "
a"ffd'" dm.ldyrs or muf""h,i.s chans.swi$ suihbleenmples

Difecnri.r oullificnionsndvrlidation.
wdte dom rhetull rom md us oflNDA andNDA
Edln!rhedifrernttrns *i!h rheteimewo tnmendunngdnsdevelopmcntpMe$
\! r"ifrE;dfttma b;M; taa
w})a!n DtdAIc in SixSi8tu en epc
wnrerhetull fofr of CDSCO.
NhJ COPPs EquLcdb) pharuceuri.r indusq{

w ;*ffi;aftas.m@;; ilc-up in Phmr indsty? sl,fnsd,en}"u conmoit

.1. Dis1)Nhqc-iai- ;d tuidrcn ol CDSCOwi(hspccialnenton to ib pononiccsWlEt m rhe

quft -1r icp' o'3pprolJLorrldruSin lnd:3^
"oo"rio6
INDA wi(h NDA. Dcscnbefie conlentand fomor ofINDA with speial nenrion to invei'garor
Dilldmisre

(7\5=15)
D . s 0 , r - e n . } ? e o f P d r o m ' r n o l o evy L l c . . . n p o e
, \ c s b . s . o , n r o nS U P \ r 9 1 d ; i n r
Di$u$ rheolc olBionrisrics in Dhmaccutical developnenL
wi,F,n bnefabour lhevmou5TT asence\ in India.
wnb lI! o€Fization md tundiod of SrarcLicen$nsAudonry
\\,lE-h rbmF onp@.'i.rrcM? Itiscu$ lhesisiticmce of rQM in phmaeutical indNhv
D$cribe rhc sigdficuce ol Iechnology.nnsrer sd qualiq isk mdmgemelrin Phmeuti.al itdstv.
wh arc rbediilereni elemsnrsand goak ol Phm&eulic.l QBD?
ll iii-os sepsor"pp,.a mi drusin lndir? lr. a dfls is aln dylppfled in
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