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DTSTART:19700308T020000
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UID:2140535:Event:195690
DTSTAMP:20260526T114859Z
SUMMARY:Effective Records Management & Document Control for Medica
 l Devices
DESCRIPTION:Overview\n\nThe document management system for medical dev
 ice industry should help companies have control over critical activiti
 es such as:\n\nEstablishing best practice SOP, Deviation, CAPA, Change
  Controls, Complaint and Audit processes\nConducting Risk Assessment, 
 Root Cause Analysis and Impact Assessment where appropriate\nCreating 
 Action Plans, and verifying their effectiveness\nImproving efficiencie
 s over the QMS tasks\nReducing the risks of manual error\nEnsuring com
 pliance to 21 CFR Part 11 and immutable audit trail\nAvoid observation
 s, 483 letters and fines\nTaking the resource burden out of creating d
 ashboards/ periodic reports\n\n\nWhy should you Attend\n\n\nDo you hav
 e unapproved or outdated documents in circulation?\nAre your SOP revis
 ions being done in an uncontrolled or inefficient manner?\nDoes your p
 roduction team use confusing formats that create uncertainty in record
 -keeping?\n\nIn the Medical Device industry, companies must \"establis
 h and maintain\" documents, procedures, and records. This can involve 
 huge numbers of documents. Without a system for control, this can quic
 kly become burdensome and out of control. This can have disastrous con
 sequences in an FDA inspection.\nThis webinar will examine the ideas a
 ssociated with the development and control of quality documentation.\n
 \nAreas Covered in the Session\n\n\nQSR and ISO 13485 requirements for
  document control\nDescription of typical document control system in u
 se\nHow to create uniform documentation that is easy to follow\nEstabl
 ish systems that will speed up review of new or revised documents\nStr
 eamlined document control process\nEliminate common formatting problem
 s that create confusion\nCreate more control over controlled documents
  in circulation\nEnsure obsolete documents are removed from use\n\n\nW
 ho Will Benefit\n\nThis webinar will provide valuable assistance to al
 l regulated companies, including companies in the Medical Device, Diag
 nostic, Pharmaceutical, and Biologics fields. The employees who will b
 enefit include:\n\nDocument Control Personnel\nQA Managers and Personn
 el\nQuality Control Personnel\nFacility Maintenance and Calibration Pe
 rsonnel\nManufacturing and Operations Personnel\nAny employee Involved
  in Regulatory Audits\nExecutive Management\nDocument Control Clerks\n
 Consultants\nQuality System Auditors\n\n\nSpeaker Profile\n\nDenise Wr
 estler ASQ CQE, CQA; QA/RA Consultant at CYA Medical Device Consultin
 g, LLC with almost 15 years of experience within FDA-regulated industr
 ies including medical device and pharmaceuticals, Ms. Wrestler provide
 s quality, regulatory, and technical expertise to meet individual clie
 nt needs. Ms. Wrestler agrees with the FDA's \"least burdensome approa
 ch\" and prides herself on providing options and recommendations for e
 nsuring regulations are met without wasting precious company resources
 . \n\n\nFor more information visit https://medtechiq.ning.com/events/
 effective-records-management-amp-document-control-for-medical
DTSTART;TZID=America/New_York:20191105T100000
DTEND;TZID=America/New_York:20191105T110000
CATEGORIES:webinar
LOCATION:Fremont, CA
WEBSITE:http://www.traininng.com/webinar/effective-records-management-
 &-document-control-for-medical-devices--201073live?medtechiq-Nov-S
 eo-2019
URL:http://www.traininng.com/webinar/effective-records-management-&amp
 ;-document-control-for-medical-devices--201073live?medtechiq-Nov-Seo-2
 019
CONTACT:(510) 962-8903
ORGANIZER;CN="Joseph Wilcox":https://medtechiq.ning.com/profile/Joseph
 Wilcox
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/3635915193?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Joseph W
 ilcox":https://medtechiq.ning.com/profile/JosephWilcox
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