Who Should Attend
This course has been developed for those who supervise, implement or audit the validation of analytical methods for the quality control of small molecule pharmaceuticals, biopharmaceuticals, and biologics. The course is oriented towards, but is not limited to, professionals in Analytical Development, QA/QC and Validation professionals. Additionally, it will benefit anyone who has method validation among their job responsibilities.
Learning Objectives
Those attending this course will be provided with a thorough understanding of regulatory agency expectations for analytical method validation, as well as, being provided with the background knowledge necessary to effectively plan analytical method validation programs. Attendees will also develop expertise in writing validation protocols and reports, good documentation practices, and setting acceptance limits for analytical method validation using Quality by Design (QbD) principles. Upon completion of the course, participants will also have gained an understanding of compliant versus non-compliant practices through discussion of real-life examples of deficiencies found during regulatory audits.
Course Description
This course provides comprehensive and up-to-date knowledge of analytical method validation for quality assurance and control of pharmaceuticals, biopharmaceuticals, and biologics; bioanalytical method validation is also covered briefly. These sessions also cover regulatory expectations regarding analytical method validation as contained in U.S. and International regulations and guidelines with specific emphasis on ICH guidelines.
In addition, the program will prepare attendees to develop and implement compliant method validation plans and to prepare for regulatory audits. Discussion of real-life situations regarding non-compliant practices found during regulatory audits will be discussed and the opportunity to review specific analytical method validation issues raised by attendees will be available in a roundtable format.
At time permits, participants will also have the opportunity for one-on-one consulting with the course director who has over 30 years of FDA experience.