Conference Description:

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

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. Past employers / clients include

Royal Berkshire Hospital, Roche, Novartis, Genentech,

PriceWaterhouseCoopers & Stanford Hospital.

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

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]