Dr. David Lim

Speaker: Dr. David Lim

Webinar Code: OCH 100 421

Webinar Duration: 60(Minutes)

Use of Excel Spreadsheets in FDA-Regulated Environments under 21 CFR Part 11

Webinar Date: Wednesday 21st of August 2019 10:00 AM PDT | 01:00 PM EDT
Available Options
{ For One participant }

{ Unlimited Access for Six months }

{ Live + Recorded webinar }

{ Live Access for 10 Participants }


Why you should attend:

This seminar will provide great opportunities to improve our awareness and better implement part 11 and computer system validation requirements and to avoid citations in 483s and warning letters concerning part 11 and computer system validation. 

Topic Description:

This seminar is intended to help you get familiar with the 21 CFR Part 11 Compliance Requirements for Excel Spreadsheets.

 In particular, this seminar is intended to present “How to Develop and Validate Excel Spreadsheets for 21 CFR Part 11 Compliance.” 

 In FDA-regulated industry, 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. 

 This seminar will help firms 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.

 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….”

 This seminar 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.

Areas Covered:

  •        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 will benefit:

  •            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