Clinical Research Audits and Inspections Regulatory Compliance Training - Live Webinars, Recordings & CDs

This Clinical trial auditing training will provide an understanding of how to conduct compliant and successful clinical trials by defining FDA clinical trial audit procedures, audit program, audit planning and audit preparation.

This webinar on Trial Master File (TMF) for clinical research sites will show how you can create an FDA compliant TMF to ensure that it will pass inspection by FDA investigators and QA Auditors.

This webinar on issue detection and escalation in clinical trial settings will review the responsibilities of sponsors, investigators, IRB, vendors and CROs in clinical trial setting to maintain compliance. We will discuss how you can proactively monitor to prevent issues and in case of issue detection, escalate them.

This webinar on clinical trial audit/ inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them.

This webinar on clinical site audit/ inspection will outline the responsibilities of the Investigator and the clinical research coordinator during and after site audits/inspections and show what you must do to ensure preparedness at all times.

This Clinical trial auditing training will provide valuable assistance how to conduct clinical trials both using internal resources and also those that outsource the function to CRO’s in pharmaceutical and biotech industries. How to assure your clinical trials are in compliance and meet the agencies requirements.

Discussion on role and responsibilities of clinical trial investigator and the legal and regulatory requirements to follow for Good Clinical Practices (GCP)

This Clinical Trial training will provide a detailed review of the FDA regulations for Clinical Trials Process. This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics.