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DTSTART:19700308T020000
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UID:2140535:Event:471069
DTSTAMP:20260522T173918Z
SUMMARY:Laboratory Inspection and Auditing
DESCRIPTION:Quality auditing of pharmaceutical quality control laborat
 ories is an important activity for those performing due diligence or m
 onitoring the performance of a sub-contractor. Besides covering GMP re
 gulations affecting pharmaceutical quality control, this one-day cours
 e is designed to provide the non-specialist with the necessary knowled
 ge to understand the quality significance and risk associated with dif
 ferent analytical operations.\nBy the end of the course, attendees wil
 l be able to:\n\nIdentify non-conformance to cGMP regulations in analy
 tical operations\nUnderstand the key steps in the analytical process\n
 Recognize commonly-used analytical techniques and instruments\nAppreci
 ate the significance of pharmacopoeias in analytical operations\nUnder
 stand the requirements for controlling reference standards, reagents a
 nd important consumables\nAppreciate the importance of GMP controls ov
 er analytical method suitability (validation, verification and transfe
 r)\nClassify analytical instruments according to quality risk and unde
 rstand the qualification requirements for each class\nUnderstand curre
 nt expectations for data integrity controls, including electronic data
  systems\n\nLearning Objectives:\n\nUS and EU GMPs relating to quality
  control operations\nAppropriate GMP controls at each step in the anal
 ytical process\nInformation provided by different analytical technique
 s\nPharmacopoeias – contents, structure and regulatory significance\
 nSignificance of ICH guidance\nQuality requirements for reference stan
 dards and reagents\nWhat are critical consumables and how should they 
 be controlled?\nControl of analytical methods over their lifecycle\nAp
 propriate qualification of analytical instruments\nData integrity – 
 current expectations\n\nWho will Benefit:\n\nGMP auditors\nQuality ass
 urance professionals\nLaboratory managers\nQuality management\n\n\n\n\
 n\n\nFor more information visit https://medtechiq.ning.com/events/labo
 ratory-inspection-and-auditing-1
DTSTART;TZID=America/New_York:20220316T100000
DTEND;TZID=America/New_York:20220316T170000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/laboratory-inspection-auditin
 g-seminar-training-80636SEM-prdsm?channel=MedTech%20I.Q
URL:https://www.complianceonline.com/laboratory-inspection-auditing-se
 minar-training-80636SEM-prdsm?channel=MedTech%20I.Q
CONTACT:8887172436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/10038455066?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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