Laboratory Investigations Relating to Sample Re-Analysis: Covering the basics before being called out - ComplianceOnline Laboratory Webinar 2010

  • 19 Nov 2010
  • Webinar

Description

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.



Why Should You Attend:
Unexpected results in acceptable assays usually reflexively trigger calls for re-analysis by clinical managers or non clinical study directors. Before re-analysis is initiated compromising the sample, investigators must rule out pre-analytical errors, mislabeling, misdosing, delayed or accelerated sampling, subject variables (concurrent meds, fasting compromised, etc). This session will discuss several suggested procedures, hopefully avoiding unnecessary re-analysis. If re-analysis is still indicated at the end of the investigation, this session will suggest procedures.

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

Past Events

Important

Please, check "Laboratory Investigations Relating to Sample Re-Analysis: Covering the basics before being called out - ComplianceOnline Laboratory Webinar" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical laboratories
Science: Laboratories

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