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“In recent years,” states the Agency, “FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections.” This intensive 90-minute accredited online training course focuses on how you can look for, assess, and correct possible Data Integrity issues at your firm, and demonstrate to FDA that your CGMP data are ALCOA (attributable, legible, contemporaneously-recorded, original or a true copy, accurate). The centerpiece of our discussions will be a new Draft Guidance for Industry published by FDA which expresses the Agency’s current thinking on this crucial subject.

This 90-minute accredited course will help any new user get started by giving practical information on HPLC theory, its many modes of operation and how to ensure that the analysis and the HPLC are working properly. New HPLC users who take this course will be empowered with the tools they need to get a solid start using this analytical tool with its many valuable and versatile analytical uses.

This basic HPLC course will benefit the personnel with some HPLC experience who are developing or optimizing HPLC methods. This 90-minute accredited course will include discussions of theory of Reversed and Normal Phase, Ion Pairing and Ion-Exchange Methods. It will also give basic starting points on method development and method evaluation. The course is designed to give personnel with some HPLC experience a broader scope for how to use this invaluable analytical tool.