16/17 November 2010
Venue Central Dublin, Ireland
Speaker Dr Roland Collicott
Fee £1160.00
Early-bird rate of £1044 if booked and paid by 18 September
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This course is available as an in-house course
Overview
Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications.
This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development.
Upon completion of this course, delegates will have learned what is necessary to develop and validate methods for drug substance and drug product to comply with international regulatory guidelines.
The course is designed for:
Scientists working with HPLC who need to further their understanding of the technique in order to develop better methods faster. Scientists who have to validate methods HPLC methods in accordance with current internationally-accepted guidance. HPLC technicians working in R&D laboratories, quality control laboratories and stability testing laboratories.
Managers with a responsibility for generating regulatory submissions.
Outline of course
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
- 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
Workshop: Developing stability-indicating methods
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
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
The course will include interactive workshops
