ComplianceOnline Webinar - Laboratory Investigations Relating to Sample Re-Analysis(19-Nov-10 )

This Laboratory Investigation training will provide guidance on procedures investigating unexpected results for Non-Clinical and Clinical Trials and will discuss several suggested procedures, avoiding unnecessary re-analysis.
Areas Covered in the seminar :

  • FDA restriction and guidance covering sample re-analysis.
  • Establishment of complaint handling program.
  • What constitutes valid re-analysis.
  • CRM/CRA/Medical Officer Requests for re-analysis.
  • Pre-analytical errors and investigations.
  • Analytical errors and investigations.
  • Post analytical errors and investigations.

Who will benefit :
This webinar will provide valuable assistance to all regulated companies, since sample re-analysis issues will arise across the Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Laboratorians
  • Regulatory management
  • QA management
  • Clinical Research Managers and Associates
  • Sales personnel
  • Consultants
  • Quality system auditors

For Registration: