Date : Wednesday, June 29, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 75 Minutes Price : $245.00
Live Webinar Understanding and Implementing FDA's 21 CFR Part 11
Overview: In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures.
Register Now Instructor Profile: Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies
The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old there Ludwig Huber, Ph.D., is Director of are still many questions related to the scope and real Labcompliance and Chief Advisor for requirements of Part 11. Attendees of this seminar will learn global FDA compliance at Agilent about basic requirements and current FDA interpretations and Technologies. He is the editor of enforcement. Labcompliance, the global on-line resource for validation and Reference material for easy implementation: compliance issues for laboratories. He is the author of the books l Part 11 Compliance Master Plan - Ideal to develop or "Validation and Qualification in update your company's Part 11 program Analytical Laboratories, and l Part 11: Step-by-step implementation "Validation of Computerized l SOPs: Define and Document Scope and Controls for Analytical and Networked Systems", Part 11 Informa Healthcare. ...more l Electronic Audit Trail: Specifications, Implementation, Validation Related Products l Gap analysis/checklist: 21 CFR Part 11
ISO 13485 Gap Analysis Toolkit
Areas Covered in the Session:
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Overview on Part 11 history and requirements Current and future FDA inspections with focus on computers and electronic records Part 11 requirements that are NOT enforced any more Going through individual requirements: validation, limited authorized access to system and data, archiving and retrieval of e-records, executing electronic signatures binding signatures with records, training Recommendations for implementation and documentation Bringing existing systems into compliance with minimal effort Responsibilities of vendors and users Going through most common pitfalls Going through frequently asked questions and answers
ISO 13485 Quality Manual
Intro to ISO 13485 Presentation Materials ISO 13485 Internal Auditor Checklist more...
Your Necessity is our Priority
Click here to register for this webinar Who Will Benefit: l
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Everybody using computers in FDA regulated environment? Part 11 groups in Bio(pharmaceutical) and device industry System owners Software developers IT managers and system administrators QA managers and personnel Analysts and lab managers Validation professionals Training departments Documentation department Consultants
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
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
Published on Jun 8, 2011
In 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and han...