Analytical Method Qualification and Validation (Biotech)
Venue: Online Event
|Event Date/Time: Jun 08, 2012||End Date/Time: Jun 08, 2012|
Execution of a method validation is a resource intensive activity, both in terms of manpower, equipment usage, time, and money. The more the process is well defined and understood, the greater the potential for an efficient project. The less the process and its elements are understood, the greater the chance for delays and additional resource expenditures. There is confusion and a lack of guidance over what constitutes a method qualification compared to a method validation, and what are the requirements for different phases of validation, what is needed at each product phase (I,III,commercial), and what to do when there are failures within a validation. Inclusion of a CRO as an additional factor in this plan potentially escalates areas that need resolution-differences in quality systems, validation requirements, and reports to name a few. Communication without common definitions and understanding of the terms can lead to areas of confusion, project misdirection, and missed timelines.
This training will enable the user to understand what is the difference in these terms - qualification and validation, how each term applies to the group of methods for which the user is responsible, and when each may be applicable. There are some essential elements of entry for a method for both qualification and validation- and these elements will be reviewed (development reports, qualification reports, ICH category defined for methodâ€¦). In addition, there can be excursions of various types in qualification/validation activities-and potential ways to address these will be covered.