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DTSTART:19700308T020000
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UID:2140535:Event:62651
DTSTAMP:20260521T054515Z
SUMMARY:Validation and Use of Excel® Spreadsheets in Regulated Enviro
 nments
DESCRIPTION:This excel validation training/ webinar will demonstrate h
 ow to design spreadsheets for part 11/GxP /SOX/HIPAA, document plannin
 g, specifications, installation, testing and changes to meet FDA requi
 rements.\n\nWhy Should You Attend:\nExcel® Applications are widely us
 ed in laboratories, offices and manufacturing e.g., for data capture, 
 data manipulation and report generation. Regulations such as HIPAA, Sa
 rbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of sof
 tware and computer systems to demonstrate and document data accuracy, 
 integrity and confidentiality. Out-of-the box Excel® has not been des
 igned for regulated environments. However, with a good knowledge of Ex
 cel® capabilities combined with good procedures and practices on how 
 to validate and use Excel® the requirements can be met. This webinar 
 will demonstrate how requirements will be met.\nHand -Outs:\nFor easy 
 implementation, Attendees will receive:\n\nUser Manual with Excel func
 tions that help to comply with FDA requirements\nSOP: Validation of sp
 readsheet applications\nSOP: Development and use of spreadsheets in re
 gulated environments\nGap analysis/checklist for Macros and Spreadshee
 t applications\nExamples for validation documents\n\nNote: These compl
 imentary hand-outs will be sent to customers on request. Please emailÂ
  customercare@complianceonline.com for these documents, stating your 
 order number, and they will be emailed to you within 4 working days.\n
 \nAreas Covered in the seminar:\n\nFDA and other agency’s requiremen
 ts for spreadsheet validation - What do inspectors ask and what docume
 nts should be available.\nHow to design spreadsheets for Part 11/GxP/S
 OX/HIPAA compliance?\nValidation during design, development, installat
 ion and on-going use.\nWhen, what and how much to test?\nDealing with 
 standard Excel functions: Recommendations from GAMP5.\nHow to ensure a
 nd validate spreadsheet integrity and security for GxP and Part 11?\nH
 ow to apply risk based validation to spreadsheet applications?\nValida
 tion of 'ad hoc' spreadsheet applications.\nHow to document planning, 
 specifications, installation, testing and changes?\nExamples from manu
 facturing, laboratories and offices.\n\n\nWho will benefit:\n\nPharmac
 eutical and medical device industry\nAll developers and users of sprea
 dsheet applications\nValidation specialists\nQA managers and personnel
 \nRegulatory affairs personnel\nProduction and lab managers\nTraining 
 department\nDocumentation department\nConsultants\n\n\nInstructor Prof
 ile:\nDr. Ludwig Huber,Ph.D., is Director of Labcompliance and editor 
 of www.labcompliance.com, the global on-line resource for validation a
 nd compliance issues for laboratories. Dr. Huber is the author of the 
 books “Validation and Qualification in Analytical Laboratories, and 
 \"Validation of Computerized Analytical and Networked Systems\", Infor
 ma Healthcare. He has given more than 200 presentations mainly on GLP/
 GMP, 21 CFR Part 11 and Validation around the world. This included sem
 inars and presentations for the US FDA, ISPE, PDA, USP, PIC/S and seve
 ral national health agencies. For more information, visit Dr. Huber’
 s website: www.ludwig-huber.com.\n\nFor more information visit https:/
 /medtechiq.ning.com/events/validation-and-use-of-excel-spreadsheets-in
 -regulated
DTSTART;TZID=America/New_York:20131205T100000
DTEND;TZID=America/New_York:20131205T103000
CATEGORIES:fda, validation
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=701242?channel=medtechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=701242?channel=medtechiq
CONTACT:+1-650-620-3915
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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