FDA's Add-On Inspections for 21 CFR 11
- Speaker: Angela Bazigos
- Product Code:GRC-90048
Live Session - How it works
- Username and Password will be sent to you within 24 hours prior to the webinar.
- Presentation handouts in pdf format will be emailed to along with the login instructions or few hours before the meeting starts.
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Recorded Session - How it works
- Login Information with Password to view the webinar will be emailed to you within 48 hours from the date the Live webinar was completed. The link to the recording is for a single person use only and it is valid for 6 months or the actual duration the recording was purchased.
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- Presentation and other handouts will be emailed to you in a pdf format.
Training CD - How it works
- Free shipment within 2 working days, from the date the webinar was completed. The presentation and other handouts will be emailed to you in a pdf format if we are unable to attach them in the CD or USB.
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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.