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Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory records are the target of inspectors. The large number of FDA Warning Letters also demonstrate that the industry struggles with either understanding or implementing the regulations.
Date :
Place : United States, Zurich, switzerland
Contact Person:Eevnt Manager
Description:
Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory records are the target of inspectors. The large number of FDA Warning Letters also demonstrate that the industry struggles with either understanding or implementing the regulations.Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory records are the target of inspectors. The large number of FDA Warning Letters also demonstrate that the industry struggles with either understanding or implementing the regulations. will be held in Zurich, switzerland,United States on date 2017-07-13
Deadline for abstracts/proposals : 10th July 2017
Organized By :NetZealous DBA as GlobalCompliancePanel
Keynote Speakers : Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences Served as team member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP® special interest group on Laboratory Systems. Presenter of the Year of the Institute for Validation and Technology Director and chief editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories. Author of the books &
Conference Highlights :Pharmaceutical development and Quality control laboratories Quality control laboratories of API manufacturers Contract laboratories Contract manufacturers Clinical Research Organisation Suppliers and service providers of instruments and computer systems
Venue :Zürich, Switzerland
Check the event website for more details.
.jpg "Analytical and other equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory records are the target of inspectors. The large number of FDA Warning Letters also demonstrate that the industry struggles with either understanding or implementing the regulations.")
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