2012 - Live web confrence on Excel Spreadsheet Compliance with 21 CFR 11 BY Compliance2go

This course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

Why should you Attend

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. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

Areas Covered in the Session

1. Requirements for Excel Spreadsheets

2. FDA Part 11 Validation Guidance

3. Compliance Problems with Spreadsheets

4. Design Specifications for 21 CFR 11 compliance

5. How does the FDA Design and Use spreadsheets

6. Documentation for Part 11

7. Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

90 Minutes Live Presentation

Who will Benefit

Quality Managers
Quality Engineers
Small business owners
Internal and external auditors
Management Reps
FDA inspectors
Consultants

About Speaker

Angela Bazigos has been accepted into the prestigious ranks of Stanford Who’s Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world.

Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years experience in the Life Sciences industry spanning project management, Quality Assurance and Regulatory Affairs. She has applied for patents aimed at speeding up Software Compliance and FDA Audits.

Angela is a member SQA (Society of Quality Assurance) as well as of the SQA CVIC (Computer Validation Initiative Committee), DIA and RAPS. She provides consulting services to Pharma, Biotech, Medical Device and CRO industries on compliance matters, including strategy, submissions, quality assurance, computer systems validation, and remediation’s following action by the FDA. She also teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management.
More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research, Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is also on the board for UC Berkeley’s Haas Business School for Executive Education in Life Sciences.