21 CFR 11 Compliance for Excel Spreadsheet

Speaker

Instructor: Angela Bazigos
Product ID: 702450
Training Level: Basic to Intermediate

Location
  • Duration: 90 Min
This Excel spreadsheet compliance training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.
RECORDED TRAINING
Last Recorded Date: Feb-2015

 

$249.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$349.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

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Why Should You Attend:

Spreadsheet applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 Compliance . However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel spreadsheet applications is required as part of a 21 CFR 11 compliant environment.

This training will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on Part 11 validation. It will discuss the common compliance problems with spreadsheets and how you can avoid them. Attendees will also learn about documentation for Part 11 compliance and future trends in compliance for Excel spreadsheets.

Areas Covered in the Webinar:

  • Requirements for Excel Spreadsheets
  • FDA Part 11 Validation Guidance
  • Compliance Problems with Spreadsheets
  • Design Specifications for 21 CFR 11 Compliance
  • Documentation for Part 11
  • Future Trends in 21 CFR 11 Compliance for Excel Spreadsheets

Who Will Benefit:

  • Regulatory VP
  • Quality VPs
  • IT VPs
  • Regulators
  • Regulatory Affairs professionals: Quality Managers, Quality Engineers, Small business
  • Owners, GxP Consultants
Instructor Profile:
Angela Bazigos

Angela Bazigos
CEO, Touchstone Technologies Inc

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx. Patent on speeding up software compliance https://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ . Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

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