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UID:2140535:Event:453850
DTSTAMP:20260416T103903Z
SUMMARY:Analytical Instrument Qualification and System Validation
DESCRIPTION:Analytical equipment should be qualified, and computer sys
 tems should be validated to demonstrate suitability for their intended
  use. To be acceptable to regulatory authorities, electronic records m
 ust comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent da
 ta integrity guidance. Recent EU and FDA reports demonstrate that qual
 ification, validation and electronic records are priority areas for in
 spection. The large number of FDA warning letters and the frequency of
  EU enforcement action in these areas demonstrate that companies somet
 imes struggle to understand or implement the regulations.\nThis 2-day 
 course guides attendees through equipment qualification, calibration a
 nd computer system validation processes from planning to reporting. It
  also explains regulatory requirements in these areas, including EU an
 d US GMPs, as well as data integrity guidance documents from national 
 and international regulatory bodies.\nThe course not only ensures a fu
 ll understanding of the regulations and guidelines for equipment and r
 ecords but helps attendees to develop a risk-based approach to complia
 nce. Interactive exercises will be dispersed into and between the pres
 entations.\nLearning Objectives:\n\nLearn about the regulatory backgro
 und and requirements for equipment qualification according to USP <105
 8> and computer system validation according to GAMP 5\nBe able to expl
 ain the difference between equipment calibration, qualification and sy
 stem validation\nLearn which equipment/systems need to be qualified or
  validated\nBe able to allocate equipment and systems to USP <1058> an
 d GAMP 5 categories and to design and execute qualification/validation
  protocols accordingly\nUnderstand the logic and principles of instrum
 ent qualification and system validation from planning to reporting\nBe
  able to develop a qualification and validation strategy\nUnderstand h
 ow to archive raw data from hybrid systems: electronic vs. paper\nBe a
 ble to define and demonstrate regulatory compliance to auditors and in
 spectors\nBe able to develop inspection-ready documentation\nLearn how
  to ensure, document and audit the integrity of GMP records\n\nWho wil
 l Benefit:\n\nIT/IS managers and system administrators\nQA managers an
 d personnel\nLaboratory managers and supervisors\nAnalysts\nValidation
  specialists\nSoftware developers\nRegulatory affairs\nTraining depart
 ments\n\n\nFor more information visit https://medtechiq.ning.com/event
 s/analytical-instrument-qualification-and-system-validation
DTSTART;TZID=America/New_York:20210211T100000
DTEND;TZID=America/New_York:20210212T170000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/analytical-instrument-qualifi
 cation-computer-system-validation-seminar-training-80617SEM-prdsm?chan
 nel=MedTech%20I.Q
URL:https://www.complianceonline.com/analytical-instrument-qualificati
 on-computer-system-validation-seminar-training-80617SEM-prdsm?channel=
 MedTech%20I.Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/8502678495?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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