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

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
Last Recorded Date: Jul-2016

Training CD

One CD is for usage in one location only.
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CD and Ref. material will be shipped within 15 business days

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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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Upcoming In-person Seminars by EX-FDA OFFICIALS
eCTD Submissions of IND and NDA/BLA to the US FDA

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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