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TZID:America/New_York
X-LIC-LOCATION:America/New_York
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TZOFFSETFROM:-0500
TZOFFSETTO:-0400
TZNAME:EDT
DTSTART:19700308T020000
RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU
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UID:2140535:Event:470403
DTSTAMP:20260602T052634Z
SUMMARY:Recordkeeping and Documentation in a GLP Laboratory (US FDA, U
 S EPA and OSHA Focus)
DESCRIPTION:GLP requires many types of documents. The seminar covers b
 oth the general issues and many specifics that laboratories can receiv
 e a non-compliance on. These range from data recording to validation i
 ssues to training records to archiving of documents.\nAn auditor can f
 ind numerous common errors and many, many others that are specific to 
 a particular laboratory. This seminar will go through many of the comp
 liance areas and point out some of both of these types. For those impl
 ementing GLP or striving to maintain certification, this course should
  point out many areas to examine that would lessen an unsatisfactory a
 udit.\nMost of the focus on a laboratory’s compliance with Good Labo
 ratory Practice (GLP) or with the analogous ISO 17025 is on items such
  as the Standard Operating Procedures (SOPs), training, quality assura
 nce testing, and the statistical assessment of performance and complia
 nce. These, however, are not all that an auditor may delve into. These
  might the bulk of an audit, yet a laboratory may still fail an audit 
 while doing well on all of these areas. Since laboratories focus on th
 ese, other areas might be ignored – the more mundane and simple area
 s, such as recordkeeping and archiving, basic laboratory operations, a
 nd safety.\n\nLearning Objectives:\nUpon completing this course, parti
 cipants should:\n\nKnow the variety of common documentation within a c
 ompliant laboratory.\nUnderstand the requirements for entering informa
 tion into logbooks and also to know some of the ways that are not comp
 liant.\nUnderstand the importance of logbooks for: chemicals, instrume
 nts, calibration, maintenance and repair, calibrations, training and c
 ompetence. Know the information suitable in each type.\nUnderstand the
  requirements for recordkeeping and archiving.\n\n\nWho will Benefit:\
 nThis course is aimed at those working in laboratories that must compl
 y with Good Laboratory Practice or ISO 17025, especially those whose r
 esults are to be reported to the US Food and Drug Administration (FDA)
 , the US Environmental Protection Agency (EPA), and the US Occupationa
 l Safety and Health Administration (OSHA). The various roles:\n\nManag
 ers and supervisors of the laboratory\nQuality officers and internal a
 uditors\nScientists and research associates\n\n\nFor more information 
 visit https://medtechiq.ning.com/events/recordkeeping-and-documentatio
 n-in-a-glp-laboratory-us-fda-us-e-1
DTSTART;TZID=America/New_York:20211108T093000
DTEND;TZID=America/New_York:20211109T173000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/recordkeeping-and-documentati
 on-in-glp-laboratory-iso-17025-seminar-training-80510SEM-prdsm?channel
 =MedTech%20I.Q
URL:https://www.complianceonline.com/recordkeeping-and-documentation-i
 n-glp-laboratory-iso-17025-seminar-training-80510SEM-prdsm?channel=Med
 Tech%20I.Q
CONTACT:8887172436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9729630472?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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