fda’s-21-cfr-part-11-add-on-inspections

FDA’s 21 CFR Part 11 Add-on Inspections

Live Webinar

  • 90 minutes
  • 49 Days Left
     Aug 08, 2019
  •   01:00 PM - 02:30 PM ET
    10:00 AM - 11:30 AM PT

In December 2010 the FDA began a project to better understand the industry’s adherence (or lack thereof) to 21 CFR Part 11. This involves the add on’ surveillance inspections of the sponsors’ computer systems during the course of the FDA’s regular inspections. There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record. It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system.

Join this session by expert speaker Angela Bazigos, where she will enable you to determine whether your company is subject to the most common violations.

Session Highlights:

  • 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?

  • What is the best strategy for future proven Part 11 compliance?

Why You Should Attend:

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. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime, FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

Who Should Attend:

  • Quality Managers

  • Quality Engineers

  • Small business owners

  • GxP

  • Consultants

  • Quality VPs

  • IT VPs


*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.


Angela Bazigos

Angela Bazigos

Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA. Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry. Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and is now on the Stanford Who’s Who Registry for contributions to the Life Sciences industry.

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