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

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