FDA’s 21 CFR 11 Inspection Assignments -Angela Bazigos-01/24/2012 - 8:30am

Event Information
Event Topic: 
FDA’s 21 CFR 11 Inspection Assignments
Event Date: 
01/24/2012 - 8:30am
Event Location: 
Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyale, CA
Speaker Information
Event Speaker: 
Angela Bazigos
Event Speaker Title: 
Event Speaker Company: 
Touchstone Technologies Silicon Valley
Event Speaker Bio: 

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.

Event Details
Event Details: 

In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the current status of 21 CFR 11, the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company and the industry, and provide guidance on how your company can ensure that they have a successful inspection.