Clinical Quality Auditing

As defined, Clinical Quality Audit is the process for improving the overall quality standard of clinical performances against the established standards. To evaluate trial conduct and compliance with SOPs, GCPs and the applicable regulatory requirements auditing needs to be independent of and separate from routine monitoring or quality control functions. It is paramount to incorporate a Quality Assurance component into your company’s Quality System. This is pivotal to ensuring that clinical research activities are conducted in compliance to applicable regulations. Auditing is used to verify and validate compliance. Clinical Auditing can be a great tool for discovering issues and rectifying them in ongoing research projects. Rather than have regulatory agencies inspection finding your studies were not conducted properly or in compliance, an audit is the preferred alternative. How do you conduct an effective audit will be reviewed in this webinar which will include preparation, auditing, documentation and follow up. This webinar will then move onto how to audit using Good Clinical Practice (GCPs) as the framework within clinical research no matter where the audit takes place including investigative sites, sponsors, or CROs. Finally the webinar will close with some information on latest trends in Clinical Quality Assurance.

Course Director: PAM DELLEA-GILTNER

Pam Dellea-Giltner is CEO and principal auditor of PDG Clinical Consulting LLC. She has over 30 years of experience in all aspects of Clinical Research Operations. Experience includes Quality Assurance/GCPs, Pre-Inspection Readiness/Audit Reponses, Project Management, Phase I-IV, post marketing and epidemiology studies, Study Management, Vendor/CRO Set up and management. She has held positions in both pharmaceutical and CRO companies including GCP Auditor, Project Manager, Clinical Research Associate, and Trial Manager. Currently she is Chairman of the ACRP CCRA Examination Committee and has been a certified CCRA since 2009.