Who Should Attend
This two-day course is designed for those who perform, supervise, manage, audit, or oversee the validation of analytical methods for the quality control of pharmaceuticals, including biopharmaceuticals. The course is oriented towards, but is not limited to, professionals in Analytical Development, Quality Control, Quality Assurance, and Validation groups. The course will also benefit those in other departments who find method validation among their responsibilities.
Learning Objectives
Upon completion of this course, attendees will have a clear understanding of regulatory agency expectations for analytical method validation and will have gained the background knowledge necessary to effectively plan analytical method validation programs. Attendees will have developed expertise in writing validation protocols and reports, good documentation practices, and setting acceptance limits for analytical method validation using Quality by Design (QbD) principles. Attendees 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 pharmaceutical and biopharmaceutical products; bioanalytical method validation is also covered briefly. The course covers regulatory expectations regarding analytical method validation as contained in U.S. and International regulations and guidelines. The guidelines of the International Conference on Harmonisation (ICH) will receive special attention and coverage. This course will prepare attendees to plan and execute effective and compliant method validation plans, and to prepare for regulatory audits. There will be discussion of real-life situations regarding non-compliant practices found during regulatory audits, and the opportunity to discuss specific analytical method validation issues raised by attendees in a roundtable format.