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HUM-MOLGEN
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FDA's 21 CFR 11 Add-On Inspections - Recent Updates - Webinar By GlobalCompliancePanel | |
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January 05, 2012 |
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GlobalCompliancePanel, Online Training
2012-02-14
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 you should 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
Price List: Live : $245.00 Corporate live : $995.00 Recorded : $295.00
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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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. |
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Deadline for Abstracts:
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2012-02-13
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Registration:
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webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com
Phone: 800-447-9407 Fax: 302-288-6884
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E-mail:
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globalcompliancepanel@gmail.com
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