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.
Discount : Get 15 % Discount as a early bird registrations. Use Promo code CGO15
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 regulation
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 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.
Who will benefit :
Small business owners
Internal and external auditors
Instructor Profile : 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. 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.
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