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


Everyday
08.00 AM 
 
1225 First Street, NE, Washington,
DC / U.S. Capitol Washington 20002



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



Location 1: Washington DC
Jun 28 - 29



Description
GxP records generated by spreadsheet calculations are electronic records and should comply with FDAs 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 FDAs 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 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. Stanfords Whos Who for Life Sciences.




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



Hilton Garden Inn Washington DC / U.S. Capitol
1225 First Street, NE, Washington, DC 20002

If you need any assistance, please feel free to call at 844-267-7299





https://worldcomplianceseminars.com/seminardetails/29
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Phone: 844-267-7299
Email: subscribe (at) worldcomplianceseminars.com
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Please note: The information on this site is submitted by users. CanadianDesi never checks accuracy of the information. Please use this information at your risk. If you have any question or concern regarding this listing, or you know that the above information is not accurate, please Contact Us. Thanks. 


 
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