FDA's 21 CFR 11 Add-On Inspections - Recent Updates

This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), And 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, 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.

Angela Bazigos
Instructor:
Angela Bazigos
Date:
Friday, May 3, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
90 Minutes

More Trainings by this Expert   Product Id : 502175

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Live + Recorded
$289 $340 Live + Recorded
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$599 $680 Corporate
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Overview:

In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. 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.

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.

Why should you Attend: 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 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.

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?

Who Will Benefit:
  • Everybody Using Computers in FDA Regulated Environments
  • IT Manager and Staff
  • QA Managers and Personnel
  • Regulatory Affairs
  • Training Departments
  • Consultants
  • Validation Specialists


Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services.

Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer,Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA Patent on speeding up software compliance https://www.google.com/patents/US8266578.

Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom includes training for Society of Quality Assurance.

Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences.




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