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Event :2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018

Dates :Thursday June 28th, 2018 - Friday June 29th, 2018

Location :Hilton Garden Inn
Hilton Garden Inn Washington DC / U.S. Capitol
1225 First Street, NE, Washington, DC 20002
1225 Dc / U.S, United States

Type :Education - International audience

Accreditation :--


Further information

2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018



Location 1: Washington DCJun 28 - 29



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

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

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.



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.



Seminar One Registration $1295|Special Group Discount Register for Four attendees $3995|




Education address :
Hilton Garden Inn
Hilton Garden Inn Washington DC / U.S. Capitol
1225 First Street, NE, Washington, DC 20002
1225 Dc / U.S
United States
tel : 844-267-7299

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2 Days Workshop: FDA 21 CFR Part 11 Compliance – Validation Seminar 2018 Pharmacy
the fda’s perspective and use of spreadsheets
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