GMP EDUCATION : Not for Profit Organization
1507
Seguidores
Personal Information
Organización/Lugar de trabajo
Mumbai Area, India India
Sector
Medical / Health Care / Pharmaceuticals
Sitio web
www.gmp.education
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"GMP Education" is a not for profit organization established with an objective to provide latest information to the Pharmaceutical Industry professional in fields like Regulations, cGMP , GDP, GCP, Drug Development, Mergers and acquisitions. " Drug Regulations" provides daily update with latest happenings in the Pharmaceutical World to its members without any charge. To obtain daily updates join the LINKEDIN group " Drug Regulations".
Etiquetas
fda
qa
ema
gmp
quality risk management
quality assurance
quality management
fda form 483
cgmp
qbd
qc
who
process validation
risk management
risk assessment
validation
qbd risk assessment
quality by design
anda
pharmaceutical quality
data integrity in pharmaceuticals
data falsification
qrm
us fda
critical process parameter
cleaning validation
regulation
quality risk managment.
ich
quality
microbilogy
csv
analytical method validation
critical quality attribute
usp
generic drug
risk
qualification
computer system validation
bio-equivalence
sterile products
fmea
nda
edqm
statistics
blend uniformity
content uniformity
water testing
usp water
sterile water
water for injection
oos
eu
part 11
stability
mhra
food and drug administration
inspections
capa
manufacturing
aseptic processing
gdp
dmf
good distribution practices
ind
annual product reviews.
total quality management
gdufa
statistical hypothesis testing
q3d
elemental impurities
pics
process capability
ppk
cpk
lif
laboratory information file
prequalification
quality metrics
refuse to file
impurities
rpn
data
compliance
usfda
maintenance
distillation
commissioning qualifications
environmental monitoring.
contamination
technology transfers
qp
purified water
water
wfi
pw
isolator
oel
containment
potent substances
ispe
gamp
out of specifications
out of specifications
revalidation
regulatory
commissioning
qualifications
serialisation
api
process monitoring
control charts
statistical quality control
annex 11
cfr
inspe
supplier qualification
documentation
transport verification
change control
product recall
market complaint
training
hold time study.
dissolution
sampling
drugs
ethics
biosimilars
biopharmaceuticals
health based limits
quality management system
warning letter
483
audits
corrective action
preventive action
noel
ba
be
packaging and labeling
gd
patent
market exclusivity
ftc
pay for delay
citizens petition
patents
paraiv challenge
pqr
release testing
experiment
pharmaceuticals
design of experiments
doe
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