Transfer of Analytical Methods for Pharmaceutical Analysis

Transferring an analytical method from one laboratory to another should be straightforward but unfortunately it is a process which is often problematic. Recognition of this has resulted in a new USP chapter <1224> and an update to chapter 6 of the EU GMP regulations. In this one day course the different approaches to transfer are explored fully and case studies are used extensively to follow the process from review of the method prior to transfer, to creating a suitable protocol with relevant acceptance criteria, and evaluating the results generated to assess whether the transfer has been successful.

Suitable for:

Anyone involved in the transfer of analytical methods. For example:  Analytical chemists, laboratory managers/supervisors, quality control analysts/managers, quality assurance managers, and regulatory affairs managers.

Please note: Familiarity with the characteristics studied during analytical method validation is necessary for this course since these are used for method transfer. The course, Validation of Analytical Methods for Pharmaceutical Analysis, is recommended.

Included:

Comprehensive course handouts; Certificate of Attendance; access to training resources via e-MTS; optional post training assessment  (leading to Certificate of Training); and post training support. Lunch and refreshments are included for open enrolment training courses.

Oona McPolin MRSC CChem CSci CIPD eLN