The purpose of this course is to provide attendees with practical information to perform and manage HPLC analyses within GMP-/FDA-regulated environments as well as ensure the integrity of the data generated. The course content includes the latest information on USP with proposed approaches on HPLC method development, validation and continued verification and new version of USP <1058> on Analytical Instrument Qualification (AIQ).
This is reinforced by outlining the requirements for ensuring data integrity. Quality by Design throughout the life of an analytical procedure is the new approach to method development and validation. The USP will be writing <1220> to complement <1224>, <1225> and <1226>. ICH Q2(R1) is also due to be updated as a consequence. The FDA method validation guidance issued in 2015 includes a section on lifecycle management, as well as the amendment of USP <1225>.
For more information and registration visit www.gmp-compliance.org