ComplianceOnline

Laboratory Investigations Relating to Sample Re-Analysis: Covering the Basics Before Being Called Out

Instructor: Edward O Connor
Product ID: 701439
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$349.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar on laboratory investigation will provide guidance on procedures used in 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 Webinar:

  • 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

Instructor Profile:

Dr. Edward O’Connor, PhD, is a consultant supporting Bioanalytical method development, validation and application to non clinical and clinical sample analysis. His background includes directing these efforts at a number of CROs including Tandem Labs, TherImmune, Covance, Oread and Mason Research as well as Biotechs MedImmune, Biogen and Elusys.

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