Clinical Quality Auditing

Auditing, which is independent of and separate from routine monitoring or quality control function, should be to evaluate trial conduct and compliance with SOPs, GCPs and the applicable regulatory requirements.

Incorporating a Quality Assurance component into your company’s Quality System is the start of ensuring that clinical research activities are conducted in compliance to applicable regulations. Auditing is used to verify that compliance.

Auditing can be a powerful tool for finding issues and correcting them as research is being conducted and is preferred over regulatory agencies finding your studies were not conducted properly or in compliance. This webinar will review the general principles about how to audit including preparation, auditing, documentation and follow up.

This webinar will move into 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. Then the webinar will close with some information on latest trends in Quality Assurance.

Areas Covered in the Session :

  • General principles for auditing
  • Steps for preparing and completing an audit
  • Framework of using Good Clinical Practices
  • Use of Tools and Processes
  • Trends in Quality Assurance
Who Should Attend:

  • CEO’s
  • Contract VP’s
  • Quality Departments
  • Regulatory Affairs Departments
  • IT Departments
  • Contract Personnel
  • GxP Personnel
  • Consultants

FDB3191

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.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.