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DTSTART:19700308T020000
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UID:2140535:Event:68839
DTSTAMP:20260523T043927Z
SUMMARY:Webinar on Validation and Use of Excel® Spreadsheets in Regul
 ated Environments
DESCRIPTION:Description :\nExcel® Applications are widely used in lab
 oratories, offices and manufacturing e.g., for data capture, data mani
 pulation and report generation. Regulations such as HIPAA, Sarbanes Ox
 ley Act and FDA's GxP and 21 CFR Part 11 require users of software and
  computer systems to demonstrate and document data accuracy, integrity
  and confidentiality. Out-of-the box Excel® has not been designed for
  regulated environments. However, with a good knowledge of Excel® cap
 abilities combined with good procedures and practices on how to valida
 te and use Excel® requirements can be met. For example, the FDA is wi
 dely using Excel® and complies with its own regulations.\nFor easy im
 plementation, attendees will receive\nSOP:  Validation of spreadsheet
  applications\nSOP:  Development and use of spreadsheets in regulated
  environments\nGap analysis/checklist for Macros and Spreadsheet appli
 cations\nAreas Covered in the Session :\nRegulatory requirements for s
 preadsheets; FDA Part 11 and GxP\nRecent FDA inspectional observations
  and warning letters\nRecommendations from the new GAMP®5 and EU Anne
 x 11\nHow to design spreadsheets for compliance.\nHow to design, ensur
 e and validate spreadsheet integrity.\nWhen, what and how much to test
 ?\nValidation of standard/native Excel functions?\nHow to apply risk b
 ased validation to spreadsheet applications\nValidation of 'ad hoc' sp
 readsheet applications.\nHow to document planning, specifications, ins
 tallation, testing and changes\nExamples from manufacturing, laborator
 ies and offices\nWho Will Benefit:\nEverybody developing and using Exc
 el Worksheets for regulated environments\nDevelopers and users of spre
 adsheet templates\nLab Supervisors and managers\nQA managers and perso
 nnel\nQC managers and personnel\nIT managers and personnel\nAnalysts a
 nd lab managers\nValidation groups\nTraining departments\nDocumentatio
 n department\nConsultants\nTeachers\n\nFor more information visit http
 s://medtechiq.ning.com/events/webinar-on-validation-and-use-of-excel-s
 preadsheets-in-regulate-1
DTSTART;TZID=America/New_York:20160322T130000
DTEND;TZID=America/New_York:20160322T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=FDB1764
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=FDB1764
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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