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DTSTART:19700308T020000
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UID:2140535:Event:430617
DTSTAMP:20260530T022020Z
SUMMARY:Quality Control Laboratory Compliance - cGMPs and GLPs
DESCRIPTION:FDA inspection and oversight of quality control (QC) labor
 atories are essential elements of the agency’s evaluation of the com
 pliance status of regulated companies representing multiple industries
  - pharmaceuticals, biologics, medical devices, as well as foods and c
 osmetics - as well as the contract QC laboratories which service these
  industries. Lack of compliance can result in severe regulatory action
 s, criminal liability, fines, and the inability to obtain product appr
 ovals.\nThis course will examine the fundamental requirements for all 
 QC laboratories subject to FDA inspection, recent trends from FDA insp
 ection reports and enforcement actions. In addition, this course will 
 include a list of relevant regulations and guidelines and demonstrate 
 how quality control and quality assurance personnel can monitor indust
 ry practices to stay “current” with FDA requirements (cGMPs and GL
 Ps).\nLearning Objectives:\nKey goals of the conference will include l
 earning:\n\nThe basics of FDA law and regulations governing QC laborat
 ories responsible for testing research materials, components of FDA-re
 gulated products, and finished FDA-regulated products (pharmaceuticals
 , biologics, medical devices, cosmetics, and foods).\nLaboratory organ
 ization, personnel qualification and training requirements.\nDocumenta
 tion and record-keeping requirements, including e-records and data int
 egrity.\nSample integrity requirements.\nManagement and control of sta
 bility (shelf-life) studies.\nAnalytical methods verification and vali
 dation.\nManagement and control of laboratory instruments.\nManagement
  and control of laboratory supplies.\nProper conduct of laboratory inv
 estigations.\nConsequences of laboratory non-compliance.\n\nWho will B
 enefit:\nSenior directors, managers, supervisors and those who have re
 sponsibility for ensuring that QC laboratory operations and practices 
 comply with current good manufacturing practices and good laboratory p
 ractices.\n\nQuality Assurance\nQuality Control\nResearch & Developmen
 t\n\n\nFor more information visit https://medtechiq.ning.com/events/qu
 ality-control-laboratory-compliance-cgmps-and-glps
DTSTART;TZID=America/New_York:20210113T090000
DTEND;TZID=America/New_York:20210114T160000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/quality-control-laboratory-co
 mpliance-cgmps-and-glps-seminar-training-80085SEM-prdsm?channel=MedTec
 h%20I.Q
URL:https://www.complianceonline.com/quality-control-laboratory-compli
 ance-cgmps-and-glps-seminar-training-80085SEM-prdsm?channel=MedTech%20
 I.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/8262635895?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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