Homewood Suites by Hilton San Diego-Del Mar11025 Vista Sorrento Parkway, San Diego CA 92130., 11025 Vista Sorrento Parkway

San Diego,

CA,

US,

ZIP: 11025

Phone: 858.720.9500

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.
 

Areas Covered

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

Learning Objectives

This 2 Days Workshop is intended for professionals in the 
•  Pharmaceuticals
•  Biotech
•  Medical Device
•  Radiological Health
•  Blood Products
•  Companion Animals
•  Food
•  Cosmetics
•  Tobacco
•  Academia Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

 

Course Outline:

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

Lecture 8: Quality Assurance for Excel CSV

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

 

Angela BazigosCEO 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.