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Laboratory Investigations Relating to Sample Re-Analysis

Laboratory Investigations Relating to Sample Re-Analysis

Venue Name: Online Webinar
Country: United States of America
City: Palo Alto
Number of Attendees: Unknown
Webinar or Virtual Event: Yes
Keywords: Laboratorians,Regulatory management,QA management,Clinical Research Managers and Associates,Salespersonnel,Consultants,Quality system auditors
Start Date of Conference:: 12-17-2009
End Date of Conference: 12-17-2009
Description of Conference: 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.

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