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Analytical 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 are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.
Date :
Place : United States, Boston
Contact Person:Paula Edwards
Description:
Analytical 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 are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.Analytical 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 are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations. will be held in Boston,United States on date 2017-09-15
Deadline for abstracts/proposals : 7th September 2017
Organized By :New York Events List
Keynote Speakers : Director and Chief Editor, LabCompliance Dr. Ludwig Huber is Director and Chief Editor of www.labcompliance.com, the global on-line resource for validation and compliance issues for laboratories . Mr. Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He is also the Chairman, presenter and panel discussion member at US-FDA industry training sessions and conferences. He served as a team member of PDA's task forces "21 CFR
Conference Highlights :Attendees will: Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP Guides Be able to explain the difference between equipment calibration, qualification and system validation Learn which equipment/systems need to be qualified or validated Be able to allocate equipment and systems to USP <1058> and GAMP categories and to design and execute qualification/validation proto
Venue :Boston, MA, United States
Check the event website for more details.
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