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

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Get Tips to Develop Excel Spreadsheets for 21 CFR Part 11 Compliance

In FDA-regulated industries, it is imperative that firms should demonstrate FDA-compliant implementation of 21 CFR Part 11 (Part 11) requirements applicable to manufacturers for drugs, biologics/biosimilars and medical devices including IVDs.

FDA frequently states, “failure to maintain complete data; failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data; “failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system….”

Join this session, where expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA, will help you and your firm to adequately develop and implement part 11 and Excel spreadsheet computer system validation. Adequate implementation of Excel spreadsheets for Part 11 compliance will ensure quality and integrity of GxP data and avoid FDA enforcement actions leading to 483s and warning letters.

This session will provide great opportunities to check your current practices and/or also to ensure your compliance for part 11 requirements for Excel spreadsheets of GxP data. It will help you get familiar with the 21 CFR Part 11 compliance requirements for Excel spreadsheets in straightforward and practical manner.

Session Highlights

  • Applicable statute(s) and regulations
  • Definitions
  • Compliance requirements for Excel spreadsheets under 21 CFR Part 11
  • Excel spreadsheets for GxP data
  • Protecting Excel spreadsheets
  • FDA enforcement actions on the Excel spreadsheets
  • How to avoid FDA 483s and warning letters
  • Excel and computer system validations
  • Excel data validations
  • Implementing Excel audit trails
  • Excel validation documentation requirements
  • PASS-IT recommendations: Best practices

Who Should Attend

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the FDA Regulatory Pathways For New Drugs and Generics

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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