FDA Good Clinical Practice Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will provide invaluable assistance to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. All Clinical Research protocols have a prominent safety monitoring plan as part of the overall research plan / protocol. This "plan" is to ensure the safety of participating subjects and to ensure the validity and integrity of the data.

This presentation reviews key ICH guidelines to directly correlate them with FDA Compliance Program Guidance Manuals that FDA investigators use to conduct GCP inspections. This webinar will provide critical assistance to FDA regulated companies currently conducting or preparing to conduct clinical trials.

This Clinical Trial training will helps in implementing Metrics that can be used as clinical trial performance improvement indicators.

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.