In December 2010 FDA started the Part 11 inspection initiative. This has now led FDA to stepping up 21 CFR 11 inspections with the result that 21 CFR 11 citations are rising algorithmically and have become a favorite area for inspection violations. This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.
Areas Covered in the Session:
What is FDA’s most current thinking related to computers and electronic records?
What are the inspection trends?
What are most frequent recent citations for Part11?
What are the most frequent deviations for computer system validation?
Under which circumstances can inspectors exercise enforcement discretion?
How important is risk based Part11 compliance?
How to create 21 CFR 11 compliance at your company
Who will benefit:
Everybody using computers in FDA regulated environments
IT manager and staff
QA managers and personnel
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Outsourced FDA Compliance Department”. She has almost 30 years experience in the Lifesciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and works consults to Pharma / Biotech / Medical Device and CRO industry on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teached classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management. More recently, Ms. Bazigos was selected to co-author 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 Business School for Executive Education in Life Sciences and on the Stanford Registry for Women’s Who’s Who.
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