2-day In-person Seminar

Excel Spreadsheet Validation 2018: Tools and Techniques to Meet FDA Requirements

November 15th & 16th, 2018

Time: 9:00 AM to 6:00 PM

Salt Lake City, UT

Venue: Hilton Garden Inn Salt Lake City Airport

Director : Angela Bazigos

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,495.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $4,485.00
      $7,475.00 You Save: $2,990.00 (40%)*

  Register for 10 attendees   Price: $8,222.00
      $14,950.00 You Save: $6,728.00 (45%)*
Course "Excel Spreadsheet Validation 2018: Tools and Techniques to Meet FDA Requirements" 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. 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, or laboratory or manufacturing data.

This makes spreadsheets a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training. However, this has resulted in spreadsheets being among the most under-documented systems used in GxP environments because:

  • 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
  • lack of knowledge that spreadsheets need to be validated
  • lack of knowledge on how to validate spreadsheets
Consequently, Spreadsheets have become "low hanging fruit" during FDA or other regulatory inspections and many warning letters have been issued.

Areas Covered in the Session:

Part 11 / Annex 11 Computer Systems Validation (CSV) is be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets. It will address the following topics:

  1. Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.)
  2. Risk Based Approach and Controls to Excel Spreadsheets (incl. Excel specific risks)
  3. Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11)
  4. The FDA's Perspective and Use of Spreadsheets
  5. Examples of Typical Approaches for Excel Validation
  6. How to tailor your risk based methodology to Excel to determine the level of validation required
  7. 483s and Warning Letters for Excel and other Spreadsheets
  8. Quiz: Test your understanding of Computer Systems Validation for Excel

Who will benefit:

  • VP of IT
  • Director of IT
  • Quality Managers
  • Project Managers (for CSV / IT)
  • Validation Specialists
  • Database Administrators
  • System Administrators
  • Directors / Senior Directors of Discovery
  • Directors / Senior Directors of Development
  • Directors / Senior Directors of Commercialization
  • Document Managers
  • Training Managers
  • Regulators

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 1: Excel Risk Assessment & Requirements

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

Lecture 2: Excel Functional & Design Specification

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

Lecture 3: Verification & Testing for Excel CSV

  • Traceability Matrix
  • Verification and Testing
  • Exercise Creating Excel Validation Scripts
  • Validation Report
  • Validation Registry
  • SOPs

Lecture 4: Quality Assurance for Excel CSV

  • How to audit Excel CSV projects
  • Excel 483s and Warning Letters
  • Excel Validation Jeopardy !!!

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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

Angela Bazigos

CEO, Touchstone Technologies Silicon Valley

Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ 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 LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

Location: Salt Lake City, UT Hotel: Hilton Garden Inn Salt Lake City Airport   4975 Wiley Post Way, Salt Lake City, Utah, 84116, USA

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