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21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection

 
  February 25, 2010  
     
 


GlobalCompliancePanel, Online
March 4, 2010


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. 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.
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: Jasmin NUHIC
Sr. Compliance Quality Engineer, Medtronic

Jasmin NUHIC serves a major medical devices OEM as a Sr. Compliance Quality 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 attendance and appreciation.
 
Deadline for Abstracts: March 2, 2010
 
Registration:
Thursday, March 4, 2010  
10:00 AM PST | 01:00 PM EST
Live live online training only for one participant
Price: $245.00
 
 

Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)
Price: $995.00
E-mail: webinars@GlobalCompliancePanel.com
 
   
 
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