2018 - Spreadsheets for 21 CFR 11 Compliance 2018
Date2018-08-10
Deadline2018-08-08
VenueFremont, USA - United States
KeywordsExcel Spreadsheets; Quality Engineers; Small Business Owners
Topics/Call fo Papers
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-AT-compliance4All.com
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-AT-compliance4All.com
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- Best Practices to Support FDA Computer System Validation
- Historical Perspective of the Part 11 Regulation
- Project Management for Non-Project Managers 2018
- International Conference on Viral Infection and Immune Response
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Last modified: 2018-06-14 15:30:17