Managing Clinical Deviations and CAPAs in a proven Quality Management System

Webinar description

Traditionally Life Science CAPAs have been seen as residing exclusively in GMP operations.  With increasing agency focus on Clinical Trials, the CAPA has found a new home in GCP operations.

Deviations from clinical trial protocols and Good Clinical Practice can occur throughout clinical trials, and require CAPAs to ensure resolution.

  • How do you ensure that your company has a well-defined process to capture, investigate and resolve these events?
  • Can you communicate the necessary actions to insure that deviations from protocols, SOPs and GCP are not repeated?

The ability to track and resolve these events (in accordance with regulatory requirements) and be certain that the sites are provided with current, up to date documentation is vital in order to prevent recurrence of the deviations.

Listen to this webinar to learn how to:

  • Ensure that the sponsor's SOPs are clearly communicated and that trial monitors are correctly trained (with electronic signature attestation)
  • Monitor, identify and report clinical deviations in accordance with regulatory requirements
  • Identify deviations from standard clinical practice that may result in patient harm and prevent near misses / mistakes in clinical care

Featured Speaker

Warren Perry, BIOVIA, GRCP Compliance Consultant

Duration: 56 mins

Originally aired: