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You are here: Home Webinars Details - Understanding and Preparing for System Based Inspections

Webinars

Event 

Title:
Understanding and Preparing for System Based Inspections
When:
11.02.2010
Category:
Laboratory Environments and Systems

Description

Webinar Date: November 2, 2010   Time:  11:00 to 11:30 PST

Click here to Register

Summary:

A laboratory audit is a necessary process in evaluating the state of a laboratory's quality system. For FDA-regulated labs, quality audits are required to help improve the quality, accuracy, and integrity of test results and other laboratory data.  Although every audit and inspection approach is unique, the audit and inspection process is similar for most engagements and normally consists of four stages: Planning (sometimes called Survey or Preliminary Review), Fieldwork, Audit Report, and Follow-up Review.  Evaluating and covering bases for all the above mentioned 4 stages will give you and your operation confidence on an inspection or audit.  

Join us on Tuesday, November 2, 2010 to discuss:

  • Risk based approach system for Laboratory Systems.
  • Quality based approach to Laboratory Systems
  • Four Stages of Inspections and Audits, and preparing for them.
  • Discussion of some FDA System observations and possible prevention scenarios.

Sponsored By: USDM's Laboratory Practice  Learn More

Visit our website to register for additional Laboratory Webinars 


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About USDM

USDM is a leading global consulting firm focused on life sciences.  We specialize in regulated business processes, with an emphasis on compliance and performance.

USDM provides innovative services and solutions that enable life science companies to achieve and maintain compliance across the entire enterprise.