2018 - Laboratory Investigations for Out of Specification Results
Date2018-07-25
Deadline2018-07-25
VenueOnline event, USA - United States
Keywords"Laboratory investigations; Laboratory Excursions; Aboratory Deviations
Topics/Call fo Papers
Learning Objectives:
To understand the requirements for investigations when dealing with pharmaceutical drug substances and products; to understand how to effectively control and conduct a laboratory investigation for unknown causes.
Areas Covered in the Webinar:
ICH guidelines for investigations
21 CFR 210 & 211 requirements for investigations
Relevant investigational tools
Initiation of an investigation
Controlling the scope of an investigation
Finding acceptable resolution
CAPA
Root causes
To understand the requirements for investigations when dealing with pharmaceutical drug substances and products; to understand how to effectively control and conduct a laboratory investigation for unknown causes.
Areas Covered in the Webinar:
ICH guidelines for investigations
21 CFR 210 & 211 requirements for investigations
Relevant investigational tools
Initiation of an investigation
Controlling the scope of an investigation
Finding acceptable resolution
CAPA
Root causes
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Last modified: 2018-06-01 12:50:08