21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel

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21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                   


    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


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posted:8/10/2012
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Description: 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.