21 cfr part 11

Live Webinar on : 21 CFR Part 11: How to Succesfully Prepare for and Host an FDA Inspection - Primer For Success - Wednesday, 24 August 2011, 01:00 PM EST / 10:00 AM PDT (45 Minute) Get 15 % Discount as a early bird registrations. Use Promo Key : CGO15 Free Handouts:Related Technical Document : Attendees will receive 30+ commonly asked questions; 21 CFR Part 11 regulation; Sample internal/external audit/inspection checklist based on 21 CFR Part 11 regulationWho will benefit Quality ManagersQuality EngineersSmall business ownersInternal and external auditorsManagement RepsFDA inspectorsConsultantsPricingLive ( Single registration ) : $189.00Group ( Max 10 Attendee): $499.00 Description Short and quick overview of the Part 11 regulation; detailed description of HOW TO prepare for an FDA inspection when and where Part 11 is in scope or the scope of the inspection; detailed description of HOW TO handle the FDA inspection during the inspection itself; some trends when it comes to Part 11 inspections; commonly asked questions; warnning letters examples; and what the future holds when it comes to Part 11.Why should you attend: More and more organizations are striving to 'go green' and develop 'sustainable' organization's strategies, which almost always includes using more and more of the computer technologies. Part 11 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 organization do not know how to best prepare for such inspections.In a time of global economy when and where time is of essence, having an ability to accessÂ 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..About Speaker:Jasmin NUHIC serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more.Â Jasmin NUHIC has conducted Webinars on this and other topics with high attendace and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn. <br />For any assistance contact us at support@compliance2go.com or call us at 877.782.4696<br />https://www.compliance2go.com/index.php?option=com_training&speakerkey=5&productKey=14<br />

21 cfr part 11

by supportc2go on Aug 12, 2011

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21 cfr part 11 Document Transcript