Issuu on Google+

 

 

Live Webinar  

on

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

Date & Time: Tuesday, February 14, 2012

10:00 AM PST | 01:00 PM EST

Duration: 90 Minutes

Instructor: Angela Bazigos

Location: Online

Price : $245.00

 

  

Register Now

(for one participant)

Instructor Profile:

Overview: 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. 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.

Why should you attend:

Angela Bazigos CEO, Touchstone Technologies Silicon Valley Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. 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 teaches classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy 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. ...more

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 Suggest a Topic company can ensure that they have a successful inspection.

More Webinars

Your Necessity is our Priority

Areas Covered in the Session: l

What is FDA's most current thinking related to computers and electronic records?

l

What are the inspection trends? What are most frequent recent citations for Part11? What are the most frequent deviations for computer system

l l

l

validation? Under which circumstances can inspectors exercise enforcement discretion?

l

How important is risk based Part11 compliance?

 

Click here to register for this webinar Who Will Benefit: l l l l l l l

Everybody using computers in FDA Regulated Environments IT Manager and Staff QA Managers and Personnel Regulatory Affairs Training Departments Consultants Validation Specialists

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

 


About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe


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