VIEWS: 14 PAGES: 2 CATEGORY: Healthcare Management POSTED ON: 8/10/2012
Overview: 21 CFR Part 11 is FDA regulation for electronic signatures and electronic records. It started by the pharma - it is a good regulation for medical and pharma companies but it is also a good guideline for other industries.
RAPS Approved Webinar on 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection Date & Time: Course "21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection" has been pre-approved by RAPS as Register Now eligible for up to 2.00 credits towards a participant's RAC recertification upon full completion. Instructor Profile: Wednesday, September 19, 10:00 AM PDT | 01:00 PM EDT 2012 Jasmin NUHIC Sr. Compliance Quality Duration: 2 Hours Instructor: Jasmin NUHIC Engineer, Medtronic Location: Online Price : $295.00 (for one participant) Jasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality Engineer and 21 Overview: CFR Part 11 Subject Matter Expert. 21 CFR Part 11 is FDA regulation for electronic signatures and He also served ASQ section as a electronic records. It started by the pharma - it is a good regulation chair for two consecutive terms, has for medical and pharma companies but it is also a good guideline for taught quality certification exam prep course, completed numerous other industries. software validations and obtained over 25 different certifications in Why Should You Attend: leadership, quality, software validations, and more. Jasmin NUHIC More and more organizations are striving to "go green" and develop has conducted Webinars on this and "sustainable" organization's strategies, which almost always other topics with high attendance includes using more and more of the computer technologies. Part 11 and appreciation. ...more is a regulation that regulates the technology when it comes to electronic signatures and electronic records and will be more then ever a part of the scope of the FDA inspections, yet most Suggest a Topic More Webinars organization do not know how to best prepare for such inspections. Your Necessity is our Priority In a time of global economy when and where time is of essence, having an ability to access records from any location around the world is more critical then ever, and for the same reason, electronic records will be more needed and desired in each organization. In addition, approval of documents and records in a timely fashion is absolutely needed at all times, and being able to do just that via an electronic media is understood. For both, electronic signatures and electronic records, the organization shall comply with the Part 11 regulation. Areas Covered in the Session: l Short and quick overview of the Part 11 regulation l Detailed description of HOW TO prepare for an FDA inspection l When and Where Part 11 is in scope or the scope of the inspection; l Detailed description of HOW TO handle the FDA inspection during the inspection itself; l Some trends when it comes to Part 11 inspections; l Commonly asked questions; warning letters examples; and what the future holds when it comes to Part 11. Click here to register for this webinar Who Will Benefit: l Quality Managers l Quality Engineers l Small Business Owners l Internal and External Auditors l Management Reps l FDA Inspectors l 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 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
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