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 All the Insider Tips and Tricks to Develop Excel Spreadsheets under 21 CFR Part 11


In the FDA-regulated industry, it is imperative that firms demonstrate FDA-compliant implementation of 21 CFR Part 11; requirements applicable to manufacturers of drugs, biologics/biosimilars and medical devices including IVDs. FDA has frequently released statements on the important of meeting these requirements.

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.

Join expert speaker Dr. David Lim, in this audio session to learn to adequately develop and implement part 11 and Excel spreadsheet computer system validation in your organization. Get in-depth insights to improve your awareness in-order to better implement part 11 and computer system validation requirements to avoid citations in 483s and warning letters.

Session Highlights:

  • Laws and Regulations
  • Definitions
  • Compliance Requirements for Excel Spreadsheets under 21 CFR Part 11
  • Excel Spreadsheets for GxP Data
  • Protecting Excel Spreadsheets including Cells, Rows and Columns
  • 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
  • Understand All Aspects of Part 11 Compliance Requirements for Excel
  • PASS – IT Recommendations

Who should attend:

  • Professionals in healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • IT Professionals
  • R&D
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

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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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