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.
o Anticipation of likely degradation products
+ From experience with compound
+ From forced degradation (stress testing) of drug substance, as per ICH guidance
+ What problems may be anticipated with likely degradation products?
+ Are degradation products likely to be enantiomers or diastereoisomers?
* Analytical method development
o Specificity: peak purity determination (Diode array and MS detectors)
o Reminder of the importance of resolution, separation factor (selectivity), capacity factor and column efficiency).
o Selecting the column for analysis
o Selecting the mobile phase (optimise pH etc)
o Gradient/isocratic operation appropriate?
o Calculation of mass balance and its significance
o Avoiding false identification, particularly in drug product analysis
o Consideration of ICH Q3A/B (identification of deg prods > identification threshold)
o Other attributes to be monitored during the stability study?
* Validation of stability-indicating analytical method
o To ICH Q2(R1)
o Intro/reminder of parameters to be validated
o Extent of validation
o Acceptance criteria
o Validation procedures and protocols
o Dealing with validation failures
* Transfer of stability-indicating analytical method
o In-house or external transfer
o Which parameters should be compared between originator and second lab?
o Comparative testing or re-validation?
o Reference standards and samples
o The process and communication
o Transfer protocols and acceptance criteria
o Typical pitfalls in method transfer
o What if the acceptance criteria are not met?
* Stability study documentation
o Designing the ideal stability study
o The stability protocol
o The stability report
|Contact Person:||Judy Callanan|
|Organizer State/Province: (Outside US)|
|Organizer Country||United Kingdom|
|Organizer Phone||0044 20 7193 7703|
|Organizer Fax||0044 20 7681 3582|
|Event Site/Venue||Window Conference Venue, Islington|
|Event sold out?||No|
|Multiple locations or dates?||Multiple dates but same location|
|Statistics available for most recent event held in:||NA|
|Average number in event attendance of:|
|Number in attendance of:|
|Is Registration contact information the same as Organizer Contact above?||Yes|
|Web Page ||http://pharmatrainingservices.com/AnalyticalMethodDevelopmentandValidation.htm|
|Can one register for your CE on your web site?||No|
|Can registration be made by snail (regular) mail?||Yes|
|Online housing reservations:|| |
|Do you have additional written or AV materials for sale?||No|
|If so, are they available for non-attendees as well as those attending?||NA|
|Is full tuition necessary to ensure registration?||No|
|Will there be shuttle service available?||NA|