BEGIN:VCALENDAR
PRODID:NingEventWidget-v1
VERSION:2.0
METHOD:PUBLISH
BEGIN:VTIMEZONE
TZID:America/New_York
X-LIC-LOCATION:America/New_York
BEGIN:DAYLIGHT
TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0400
TZOFFSETTO:-0500
TZNAME:EST
DTSTART:19701101T020000
RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
UID:2140535:Event:469529
DTSTAMP:20260523T205024Z
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\nIdentify non-conformances in the control of stability studie
 s\n\nLearning Objectives:\n\nUS and EU GMPs relating to quality contro
 l operations\nAppropriate GMP controls at each step in the analytical 
 process\nInformation provided by different analytical techniques\nPhar
 macopoeias – contents, structure and regulatory significance\nSignif
 icance of ICH guidance\nQuality requirements for reference standards a
 nd reagents\nWhat are critical consumables and how should they be cont
 rolled?\nControl of analytical methods over their lifecycle\nAppropria
 te qualification of analytical instruments\nData integrity – current
  expectations\n\nWho will Benefit:\n\nGMP auditors\nQuality assurance 
 professionals\nLaboratory managers\nQuality management\n\n\nFor more i
 nformation visit https://medtechiq.ning.com/events/laboratory-inspecti
 on-and-auditing
DTSTART;TZID=America/New_York:20210923T100000
DTEND;TZID=America/New_York:20210923T170000
CATEGORIES:seminae
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/9455658464?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
END:VEVENT
END:VCALENDAR