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North
American School of Information Technology
3609
Sheppard Ave. E Scarborough ON M1T 3K8
Tel: 416-335-6178 Fax: 416-335-6179
http://www.nasit.com
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| QC
Courses |
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| High
PerformanceLiquid
Chromatography
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Course
Description: |
| Module
1 |
- Basic
HPLC
separation
on
reverse
phase
- Mobile
Phase
composition/
Column/
Chemistry
/
Solvent
Selection
- HPLC
system
suitability
and
USP
compliance
- Qualitative
Analysis
- Quantitative
Analysis
/
GMP
-
GLP
Documentation
- Gradient
Vs
Isocratic
Elution
- Chem.
station
software
programming
for
automated
HPLC
run
|
| Method
Development
by HPLC |
Course
Description: |
| Module
II |
- Potency
method
development
for
active
ingredient
- Method
development
for
related
substances
- Method
development
by
using
iron
pair
reagent
for
ionizables
- Method
development
by
using
pH
control
for
acidic
and
basic
substances
|
| Analytical
Method
Validation |
Course
Description: |
| Module
III |
- System
precision
by
HPLC
/
system
suitability
- Method
precision
by
HPLC
- Linearity
by
HPLC
- Accuracy
by
HPLC
- Limit
of
quantization
by
HPLC
- Limit
of
detection
by
HPLC
- Method
validation
for
impurity
profile
|
| Instrument
Calibration |
Course
Description: |
| Module
IV |
- HPLC
Calibration
- Dissolution
apparatus
calibration
for
disintegrating
type
and
non-disintegrating
type
tablets
- UV
calibration
for
wavelength
accuracy
and
linearity
- Karl
Fisher
calibration
for
moisture
determination
- pH
meter
two
point
and
multilevel
calibration
- Analytical
balance
calibration
|
| UV
Spectrophotometer |
Course
Description: |
|
Module
V |
- Basic
UV
theory
and
Beer
Law
/
Multilevel
calibration
and
Single
Point
calibration
/
Regression
analysis
/
Confidence
- limits
/
GMP
-
GLP
Documentation
- Qualitative
analysis
using
UV
- Content
uniformity
of
tables
using
UV
- Quantification
of
active
%
dissolved
from
dissolution
analysis
of
tables
- Quantification
of
active
%
dissolved
from
dissolution
analysis
of
capsules
and
blank
correction
for
colored
capsules
- Composite
assay
analysis
of
active
(using
tablets)
- Assay
determination
of
raw
material
using
UV
|
| Dissolution
Analysis |
Course
Description: |
Module
VI |
- Basic
dissolution
theory
and
USP
Acceptance
criteria
/
GMP
-
GLP
Documents
- Operational
qualifications
of
the
apparatus
for
both
USP
I /
USP
II
- Performance
qualifications
theory
- Dissolution
analysis
of
compressed
tablets
- Dissolution
profile
analysis
of
slow
release
tablets
- Dissolution
release
rate
of
suspension
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| QA
Courses
(Module
VII) |
Good
Manufacturing
practice,
Regulation
- c and
Interpretation |
| Technical
Skill
Writing |
- Standard
Operating
Procedure
writing
for
Apparatus
/
Analytical
Operations
and
Procedures
includes
SOP
- UV
spectrophotometer
- Karl
Fisher
apparatus
- Analytical
procedure
for
dissolution
method
- analytical
procedure
for
identification,
content
uniformity,
and
assay
of
active
substances
|
|
Reports
Include: |
|
- Quality
incident
report
- Quality
deviation
report
- Out
of
specification
report
- Preventive
action
plan
report
|
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