Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance

Duration: 90 Minutes
Spreadsheets are powerful business tools, and are increasingly used in manufacturing, tracking and quality systems - as well as in generating and interpreting business data. FDA requires spreadsheets to be validated per 21 CFR 210-211, Part 820 and to be compliant to 21 CFR Part 11 in some cases.
FDA CFR 21 Part 11 Compliance
Instructor: Alfonso Fuller
Product ID: 502490
Objectives of the Presentation
  • Understand the significance of spreadsheets as software as viewed by US FDA
  • Review current FDA posture towards spreadsheets
  • Know how to conduct an audit of the use of spreadsheets in the organization
  • Recognize when spreadsheets being used should conform to FDA regulations
  • Be able to determine which spreadsheets are NOT required to be validated, and how to document
  • Be able to determine which spreadsheets do NOT trigger 21 CFR part 11 compliance
  • Know the relationship between spreadsheets and SDLC
  • Review the relationship between "validation" and "part 11 compliance"
  • Be able to plan spreadsheet validations, and integrate into overall validation planning
Why Should you Attend
Many companies struggle with spreadsheet compliance. Some are still using invalidated spreadsheets. Many companies lack an understanding of how to satisfy FDA technical validation requirements as applied to spreadsheets. Most organizations lack a clear spreadsheet compliance strategy. An unplanned 'emergency' spreadsheet validation project could paralyze the organization. This webinar will describe methods for planning and executing spreadsheet validations that satisfy FDA requirements.

Areas Covered
  • Review current enforcement posture towards spreadsheets
  • Determining which spreadsheets require validation - and which don't
  • Which spreadsheets are required to be compliant to 21 CFR Part 11
  • Technical issues discussion
  • Practical tips on gaining control over spreadsheets
  • Practical tips on spreadsheet validation
Who will Benefit
This webinar will give valuable help to FDA regulated Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. The staff members who will benefit include:
  • System owners - responsible for keeping individual systems in validation
  • QA / QC managers, executives and personnel
  • IT / IS managers and personnel
  • Validation engineers, validation specialists
  • Software quality reviewers, software quality reviewers, SQA
  • Consultants
  • Quality Engineers (QE)
  • Production and Process Engineers
  • Manufacturing Engineers
  • Design Engineers
  • Purchasing Managers
  • Purchasing Agents
  • Supplier Quality Engineers
  • Quality Supervisors
  • Quality Inspectors
  • Quality Managers
  • Quality Audit Managers
  • Quality Auditors
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Alfonso Fuller is the President of Fuller Compliance, Inc., a consulting firm that specializes in FDA quality system, software validation and software quality for pharmaceutical, biotech and medical device, nutraceutical and food manufacturers. He is a consultant, writer, and frequent presenter nationwide on quality system and software quality issues. His speaking appearances have included numerous national and statewide conferences.
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