Personal Information
Organization / Workplace
Chennai Area, India India
Occupation
Asst. Vice President- QA & RA at Malladi Drugs and Pharmaceuticals Limited
Industry
Medical / Health Care / Pharmaceuticals
Contact Details
Tags
amsavel
dr. a. amsavel
gmp
deviation
qualification
qc
analytical chemistry
oos
recall
stationary phase
capa
complaint
calibration
investigation report
principle
instrumentation
theory
instrumentation and application in pharmaceutical
dr.a. amsavel
apqr
annual verification
access
storage
cleaning of clean rooms
quantity of sample for packing
packing of sample
sample withdrawn for testing of complaint
guideline requirement
handling of reserve samples
meta data
raw data
gxp
bioburden
disinfectant
iso14644
glp
data integrity
qualification for reviewer
role of reviewer
reagent record
sample record
calibration record
audit trail
chromatograms
reprocess and rework
return goods
adverse stability trend
dmf annual update
change control
apr
requalification and revalidation
pqr
contamination control
response to customer
cleanrooms
far
trend
mrm
hepa
effectiveness of capa
air classification
environment monitoring
containment
remedial action
21 cfr § 211.198 and ich q7
sop for complaint handling
investigation
equipment
documents & records
destruction
rca
oos & complaint investigation and capa
batch rejection /disposition
conclusion on oos
minimising oos
citation on oos
oos trend
barr lab vs fda
oot
lab investigation
volumetric analysis
volumetric analysis- dr. a. amsavel
analytical method validation basic
good laboratory practices by dr. a. amsavel
pharma industry
data integrity training by dr. a. amsavel
weighing
balances
pharma qc
gcp by dr. a. amsavel
principles of nat & uses in qc lab- dr.a.amsavel
bpr review
batch release
lab safety- dr. a. amsavel
gmp-vmp
dr.amsavel
pharma job
process validation
gmp-deviation handling
lab control records
purity
strength
quality
rounding up rules
description & solubility
fda
api
reagents & solutions
frequently used gcs.
universal tests
storage conditions
packaging and storage
general notices
general chapters
monograph
usp
investigation steps
investigation process
investigation tools
deviation reporting
human error
verification of capa effectiveness
kt
fta
cause&effect
fishbone
5why
optical crystallography
thermogravimetry (tga)
differential scanning calorimetry(dsc)
xrpd
pseudopolymorphism
polymorphism
polymorph
optical isomer
ee
enantiomeric excess
chiral
factors affect the optical rotation
polarimeter
optical rotation
specific optical rotation
isomers and enantiomers
column chemistry
instrumentation & types of detectors
glc
sec
gpc
ionexchange
reversed phase
normal phase
hplc techniques
chromatographic separation
application
hplc
high performance liquid chromatography
personal hygiene guideline
emergency approval
ethical committee
formulation & dosage
faers
invitro
invivo
target
hts
post marketing data
nda and fda approval
clinical trial
preclinical research
discovery & development
drug discovery path
compliance
confidence
improvement
measurement
batch acceptance rate
stability oos rate
invalid oos rate
apr completion rate
complaint rate
cder
quality metric
molecule arrangements in solids
preparation of ploymorphs
ssnmr
spectrophotometry in the infrared region
ft-ir & raman
pharmacopiea
sample injection
packed column
capillary column
detector
corbowax
polydimethylsiloxane
chemical phase
carrier gas
column
injector
gc instrument
definition
application. chromatography
theory instrumentation
gas chromatography- principle
ichq7
sop
crm
usprs
ph.eur crs
working standard
potency
secondary standard
reference standard
ahu
hvac
air sampling
settle plate
sources of contamination
protective clothing & gowning
procedures & records
health examination
training & practice
hand wash
source of contamination and control
personal hygiene
metastasis:
mutation
genetic problem
types of cancer treatments
stages of cancers (tsm)
palliative care
radiation therapy
chemotherapy
classification of cancers
awareness on cancer
ftir spectroscopy
pharmaceutical analysis
stray light
molar absorption coefficient
molar absortivity
control of absorbance
control of wavelength
factors influence the absorption
chromophores & auxochrome
beer- lambert law
molecular absorption theory
uv &visible spectroscopy
pharma industry.
root cause
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