FDA's New Enforcement of 21 CFR Part 11
Regulatory Compliance Training- GlobalCompliancePanelApr 07,2010 - Apr 07,2010
Online Webinar, Wilmington, Delaware, United States
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Highlights
FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Just in 2007/2009, there have been about 30 Warning Letters related to Part 11 compliance, some with disastrous consequences for inspected companies. It seems that 'enforcement discretion' as stated in the 2003 guidance is not applied any more. FDA's computer expert John Murray recommended at a conference to follow 21 CFR Part 820 also for drug companies but industry needs more guidance and practical recommendations on how to respond to FDA’s new enforcement practice.
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Event Profile
- Theme: Regulatory Compliance Training- GlobalCompliancePanel
- Sponsors: GlobalCompliancePanel
- Speakers: Dr. Ludwig Huber, Chief Advisor - Global FDA compliance, Agilent Technologies
- Attendees: * IT managers and system administrators * QA managers and personnel * Analysts and lab managers * Validation groups * Software developers * Validation professionals * Training departments * Documentation department * C
Contact Details
- Contact person: GlobalCompliancePanel
- Event website: http://www.globalcompliancepanel.com/control/w_product/~product_id=600109LIVE?channel=mailer&camp=webinar&AdGroup=goingtomeet_APR07_FEB16
- Phone: 800-447-9407
- Fax: 302-288-6884
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