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PharmaTraining Limited, Window Conference Venue, 13 Windsor Street. Islington, London, N1 8QG
27 & 28 November 2012
Course Programme
DAY ONE
Analytical method development, part 1
Theory and factors affecting resolution – a reminder of the importance of
resolution, separation factor (selectivity), retention factor (capacity factor) and
column efficiency).
Selecting the HPLC separation mode (reversed-phase, normal-phase etc.)
Overview of instrumentation
Selecting the most appropriate detector
Troubleshooting
Workshop: Selecting the separation mode
Analytical method development, part 2
Gradient/isocratic operation appropriate?
Selecting the column for analysis
New column technologies
Selecting and optimising the mobile phase
The effect of pH, considering pKa of the analyte
Workshop: Selecting the column and mobile phase
End of Day One: Group discussion
DAY TWO
Developing stability-indicating methods
Requirements for a stability-indicating analytical method
Anticipation of likely degradation products
From experience with compound
From forced degradation (stress testing) of drug substance, as per ICH guidance
Note findings of stress-testing industry comparison
Are degradation products likely to be enantiomers or diastereoisomers?
Calculation of mass balance and its significance
A review of other companies’ procedures
Workshop: Developing stability-indicating methods
Overview of Chiral Separations
Chiral separation by HPLC
Validation of chromatographic methods, part 1
Introduction to ICH guidelines: ICH Q2(R1)
A detailed discussion on the parameters to be validated:
Specificity: peak purity determination (Diode array and MS detectors)
Linearity
Range
Accuracy
Precision
Detection Limit
Quantitation Limit
Robustness
System suitability testing
Validation of chromatographic methods, part 2
Extent of validation: how much work at each phase of development?
Acceptance criteria
Validation procedures and protocols
Dealing with validation failures
Workshop: Validation of chromatographic methods
End of Day Two: Group discussion and close
HPLC Analytical Method Development and Validation
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Organized by:
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PharmaTraining Ltd |
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Invited Speakers:
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Speaker:
Dr Roland Collicott, as an experienced consultant and trainer, provides assistance to the
pharmaceutical industry in the areas of chiral analysis , polymorphic characterisation, stability
studies, chemical analysis in a GMP environment, specifications and all aspects of
international CMC documentation. He also runs training courses to cover many areas of
analytical chemistry, particularly in chromatography, chiral and polymorphic analysis. He has
served as an expert witness and consulted in trials in Canada, UK, South Africa and Germany.
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Deadline for Abstracts:
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.
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Registration:
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Discount of 10% applies for booking 8 weeks in advance
Discount of 10% applies for booking more than 1 delegate
Discount of 10% applies for booking more than 1 course
Maximum discount received is 15%
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E-mail:
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judy@pharma-training-courses.com
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