Laboratory Testing and Validation Regulatory Compliance Training - Live Webinars, Recordings & CDs

This Validation training will guide attendees through the entire process from defining specifications, through developing and implementing validation experiments to FDA compliant documentation.

This 90-minute webinar on laboratory OOS investigations will review the regulatory requirements for an OOS Investigation. You will learn common regulatory pitfalls and how to structure an Investigation report that satisfactorily documents the investigation.

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

This webinar will explain the cGMP and ICH validation requirements for analytical procedures and discuss key factors that would affect validation process of analytical procedures. It will review the differences between validation and re-validation plan.

This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.

Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.

An Annual GLP training is a requirement for all personnel involved in Good Laboratory Practices (GLP) studies. The webinar course serves both as an initial training for new employees, new to GLP concepts will serving as a refresher course for experienced senior employees. The webinar provides an overview of the GLP to remind the attendees of the regulatory requirements for organizations in which bioanalytical testing is conducted.