Personal Information
Entreprise/Lieu de travail
Bruxelles Belgium
Secteur d’activité
Medical / Health Care / Pharmaceuticals
Mots-clés
usp
data integrity
analytical development
aqbd
doe
quality control
european pharmacopoeia
ep
regulatory
design of experiment
analytical target profile
analytical control strategy
analytical quality by design
rca
root cause analysis
cause and effect diagram
fishbone
ishikawa
risk assessment
method development
humidity stress
heat stress
uv stress
oxidative stress
base stress
acid stress
degradation
pharmaceuticals
stress testing
stability
validation
performance parameters
quality assurance
continuous improvement
data quality
measurement uncertainty
measurement
analytical method
iso/iec98
eurachem
research and development
r&d
analytical method development
analytical method validation
method qualification
method validation
control strategy
modr
method operable design region
design space
atp
six sigma
lean
tqm
total quality management
human error
data approval
data review
electronic records violations
root causes of data integrity violations
dynamic electronic record
staticelectronic record
data lifecycle
recording data
meta data
raw data
factorial design
analytical quality bydesign
qbd
anova
quality by design
design of experiments
heat maps
fmea
ich method design space
risk management for analytical methods
risk management
ep chapter 2.6.13
ep chapter 2.6.12
total yeast and mould count
total aerobic microbial count
qc
cfu
sop
united states pharmaceopoeia
product control
negative control
recovery
tymc
tamc
suitability protocol
method suitability
microbial limit test
international conference on harmonization
united sstates pharmacopoeia
ich
regulatory update
global regulatory update
target measurement uncertainty
process risk management
problem solving process
problem solving tools
5 why's approach
deviation investigation
oos investigations
oos process
oos
method validation.
method operable design region (modr)
failure mode and effects analysis (fmea)
risk prioritization number (rpn)
design of experiment (doe)
wet and dry analysis
laser diffraction
particle size distribution
Tout plus
Présentations
(11)J’aime
(2)Usp chemical medicines & excipients - evolution of validation practices
National Institute of Biologics
•
il y a 10 ans
New Draft FDA Guidance on Analytical Method Development & Validations.
GMP EDUCATION : Not for Profit Organization
•
il y a 8 ans
Personal Information
Entreprise/Lieu de travail
Bruxelles Belgium
Secteur d’activité
Medical / Health Care / Pharmaceuticals
Mots-clés
usp
data integrity
analytical development
aqbd
doe
quality control
european pharmacopoeia
ep
regulatory
design of experiment
analytical target profile
analytical control strategy
analytical quality by design
rca
root cause analysis
cause and effect diagram
fishbone
ishikawa
risk assessment
method development
humidity stress
heat stress
uv stress
oxidative stress
base stress
acid stress
degradation
pharmaceuticals
stress testing
stability
validation
performance parameters
quality assurance
continuous improvement
data quality
measurement uncertainty
measurement
analytical method
iso/iec98
eurachem
research and development
r&d
analytical method development
analytical method validation
method qualification
method validation
control strategy
modr
method operable design region
design space
atp
six sigma
lean
tqm
total quality management
human error
data approval
data review
electronic records violations
root causes of data integrity violations
dynamic electronic record
staticelectronic record
data lifecycle
recording data
meta data
raw data
factorial design
analytical quality bydesign
qbd
anova
quality by design
design of experiments
heat maps
fmea
ich method design space
risk management for analytical methods
risk management
ep chapter 2.6.13
ep chapter 2.6.12
total yeast and mould count
total aerobic microbial count
qc
cfu
sop
united states pharmaceopoeia
product control
negative control
recovery
tymc
tamc
suitability protocol
method suitability
microbial limit test
international conference on harmonization
united sstates pharmacopoeia
ich
regulatory update
global regulatory update
target measurement uncertainty
process risk management
problem solving process
problem solving tools
5 why's approach
deviation investigation
oos investigations
oos process
oos
method validation.
method operable design region (modr)
failure mode and effects analysis (fmea)
risk prioritization number (rpn)
design of experiment (doe)
wet and dry analysis
laser diffraction
particle size distribution
Tout plus