A Risk Based Approach to Excel Compliance with the FDA's 21 CFR 11 and the European Annex 11 (Baltimore, MD, United States - August 16-17, 2018)

  • ID: 4585564
  • Conference
  • Location: Baltimore, MD, United States
  • 2 Days
  • NetZealous LLC
  • Conference Dates: August 16-17, 2018
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Course "A Risk Based Approach to Excel Compliance with the FDA's 21 CFR 11 and the European Annex 11" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Spreadsheets such as Excel are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment. GxP records generated by spreadsheet calculations are electronic records and should comply with FDA's 21 CFR Part 11 and the European Annex 11. For critical records Part 11 controls, such as data accuracy and data integrity, should be implemented.

This seminar gives guidance on how to achieve compliance for Excel spreadsheets and other end user applications, such as small databases, in a GxP environment. While the examples given in this seminar are mainly spreadsheets, the same principles can be applied to other end user applications.

Spreadsheets are available for creating a wide range of end user applications, including customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as they are not originally designed for the regulated environment.

GxP records generated by spreadsheet calculations are electronic records and should comply with FDA's 21 CFR Part 11 and the European Annex 11. For critical records, Part 11 controls such as data accuracy and data integrity should be implemented. Currently there are no specific industry FDA guidelines on using spreadsheets in regulated environments. However, the flexibility and power of the spreadsheet allows users to create tools that range from performing simple calculations to sophisticated analysis of a major clinical study.

This is then coupled with the fact that it is easy to build spreadsheet applications without much training has resulted in spreadsheets being among the most under-documented systems used in GxP environments.

  • users regard them as part of the desktop
  • the ease with which applications can be built without much training
  • the data processing power that they can have

Consequently, spreadsheets are "low hanging fruit" as part of FDA or other regulatory inspections, and many Warning Letters have been issued.

The level and rigor of specification and verification applied to spreadsheets should be based on risk, complexity, and novelty. This seminar provides guidance on

  • What to do to create the validation deliverables required to ensure GxP Compliance for Excel
  • How to tailor a risk based methodology to excel to help determine the appropriate validation approach.
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Day 1 Schedule

Lecture 1:

  • Types of Spreadsheets
  • Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)
  • Types of Excel Spreadsheets
  • Uses of Excel Spreadsheets

Lecture 2:

  • Excel Validation at a High Level
  • 21 CFR 11 / Annex 11 & CSV - Basic Concepts
  • CSV components and deliverables

Lecture 3:

  • FDA Use of Excel Spreadsheets
  • GxP Compliance for Excel - an FDA Perspective
  • FDA Use of Compliant Excel Spreadsheets - an FDA Case Study

Lecture 4:

  • Excel Validation Master Plan (VaMP)
  • Validation Inventory
  • Determining need for GxP Compliance
  • Excel Validation Master Plan Standards
  • Exercise to create Excel Validation Master Plan

Day 2 Schedule

Lecture 5:

  • Excel Risk Assessment & Requirements
  • Risk Assessment
  • Tailoring Risk Methodology to Excel
  • Validation Plan
  • Requirements Specifications
  • Exercise on how to create Excel requirements

Lecture 6:

  • Excel Functional & Design Specification
  • Functional & Design Specifications
  • Software Configuration and Build
  • Exercise on how to create Excel Design Specifications

Lecture 7:

  • Verification & Testing for Excel CSV
  • Traceability Matrix
  • Verification and Testing
  • Exercise Creating Excel Validation Scripts
  • Validation Report
  • Validation Registry
  • SOPs
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  • Angela Bazigos Ms Angela Bazigos,
    CEO ,
    Touchstone Technologies Silicon Valley


    Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. 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 Life Sciences.

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ADDRESS

Baltimore, MD
United States

Venue to be announced shortly.

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