Webinar On 21 CFR 11 Compliance for Excel Spreadsheets

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Contact Us 416-915-4458
We Empower, You Comply!
21 CFR 11 Compliance for Excel Spreadsheets
Virtual Workplace Management Setting Tracking
and Achieving Goals
Product Id FDB1057       
Category Food, Drugs Biologics
Scheduled On Tuesday, May 20, 2014 at 1300 Hrs
Duration 90 Minutes
Speaker Angela Bazigos
To register for this webinar please visit our
website www.compliancetrainings.com
Webinar Description
In Dec. 2010, the FDA has stepped up enforcement
for 21 CFR 11 compliance with spreadsheets being
considered as low hanging fruit for FDA
inspectional findings. 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

• Requirements for Excel Spreadsheets
• FDA Part 11 Validation Guidance
• Compliance Problems with Spreadsheets
• Design Specifications for 21 CFR 11 compliance
• Documentation for Part 11
• Future Trends in 21 CFR 11 compliance for Excel
  Spreadsheets

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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 Silicon Valley, Inc. Your Passport
to Compliance. She has 30 years of experience in
the Life sciences industry spanning Project
Management, Quality Assurance and Regulatory
Affairs and has a patent aimed at speeding up
Software Compliance. Ms. Bazigos is the president
of PRCSQA (Pacific Regional Chapter of the
Society of Quality Assurance) a member of the SQA
CVIC (Society of Quality Assurance Computer
Validation Initiative Committee), ASQ, DIA and
RAPS and consults to Pharma / Biotech / Medical
Device companies as well as investment groups on
compliance matters, including strategy,
submissions, quality assurance and remediations
following action by the FDA. She teaches classes
on Compliance, 21 CFR 11, Computer Systems
Validation, and Project Management both to
investor groups and industry. 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 on the board for UC Berkeleys Business
School for Executive Education in Life Sciences
and on the Stanford Whos Who Registry for
contributions to the Life science industry