World Conference Calendar

33622 Conferences

Laboratory Investigation Out-of-Specification Results

Added by Referral on 2011-02-14

Conference Dates:

Start Date Start Date: 2011-03-10

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email: referral@complianceonline.com
Address Address: 2600 E. Bayshore Road, Online Event,Palo Alto, California, 94303, United States
Phone Tel: 650-620-3915
Phone Fax: 650-963-2556

Conference Description:

In this Laboratory Investigation training learn what constitutes an OOS observation, what are the guidance’s process & Steps to be taken in the laboratory in the event of an OOS observation.

Why Should You Attend:

Inadequate procedures for laboratory Out-of-specification (OOS) investigations remain high on the list of FDA observations. The FDA has issued a guidance on the topic, OOS procedures and investigations are still a topic of FDA Investigator review and findings. An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion.

There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this webinar we will discuss the investigation that goes on within the laboratory. Although the focus will be on the FDA Guidance, the discussion will include suggestions for a process that will meet the FDA expectations.

Note: Use this promocode(117660) for 10% discount.
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