Aug 10, 2018 | 10:00 AM | Friday

Event Location

Online

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA., Fremont, CA 94539

Neighborhood: Upper West Side

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Description

However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter.


Fri Aug 10, 10:00 AM - Fri Aug 10, 11:30 AM

Event Details

Overview:
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance.

Areas Covered in the Session:
Requirements for Excel Spreadsheets
FDA Part 11 Validation Guidance
Compliance Problems with Spreadsheets
Design Specifications for 21 CFR 11 compliance
Documentation for Part 11

Who Will Benefit:
Quality Managers
Quality Engineers
Small Business Owners
GxP
Consultants
Quality VPs
IT VPs

Speaker Profile:
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds.

Event Fee: One Dial-in One Attendee Price: US $150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

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