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Seminar Details

  1. Speaker : Jasmin NUHIC
  2. Product ID : F62138
  3. Schedule Date :
    Tuesday, December 04, 2012
  4. duration : 12:00 to 13:15 PM EST
Available purchase formats
$289 On Demand (Recording available within 48 hrs after the completion of the webinar)

$319 Play Back - Unlimited views (Recorded File available within 48 hrs after the completion of the webinar)

$399 Get Training CD

21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection - Primer For Success

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 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.
 
"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."
 
Who will benefit

 

  • Quality Managers
  • Quality Engineers
  • Small business owners
  • Internal and external auditors
  • Management Reps
  • FDA inspectors
  • Consultants

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.  Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn.



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  • Howard T. Cooper
    President
  • David N. Muchemu
    Founder and CEO
  • Jasmin NUHIC
    Sr. Manufacturing Engineer
  • Charles H Pierce
    President
  • J. Jeff Schwegman
    Founder and CEO
  • Robert J. Russell
    President & CEO
  • Jim Sheldon-Dean
    Founder
  • Angela Bazigos
    CEO of Touchstone Technologies Silicon Valley
  • Calin Enea Popa
    Founder and President
  • Jeff Kasoff
    Director of Quality
  • Lee Truax Bellows
    Founder and CEO
  • Glenda Guest
    Vice President
  • Alex Aptovcov
    Senior Clinical Research Consultant
  • David Nettleton
    Computer System Validation’s principal
  • John Chapman
    Medical Device Consultant
  • Angela Polania
    CPA, CISA, CRISC
  • Connie Valencia
    Principal
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    International Trade Consultant
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    Consultant
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    President of Ombu Enterprises
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    Director, Regulatory Affairs for RJR Consulting, Inc
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    Ph.D
  • Peter Welch
    CEO and founder of Sox International Inc
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  • Jennifer Bill
    Director of Global Regulatory Affairs
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    Management Consultant
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    Compliance Officer
  • Barry O’Brien
    Consultant
  • John Avellanet
    Founder & Managing Director Cerulean Associates LLC
  • David R. Dills
    Regulatory Affairs & Compliance Consultant
  • Dr. Linda Yang
    Associate Director
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    Consultant
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    Ofwlaw
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    Principal Consultant
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    Chief Compliance Officer
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    Ex FDA Investigator
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    Director
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    Founder and President of Statistical Outsourcing Services
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    President and Chief Scientific Officer
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    Founder and Managing Partner
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    PHD
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    FDA & Regulatory Expert
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    Chief Compliance Officer
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    FDA Expert
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    Chief Operating Officer
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    Principal Attorney
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    Principal Attorney
  • Neil F. O'Flaherty
    Principal Attorney
  • Jonathan M. Weinrieb
    Principal Attorney
  • Karl M.Nobert
  • Dr. Kosta Makrodimitris
    Director & Adviser
  • Julian Wilkins
    VP PharmaConsult US, Inc
  • J. MASON WEEDA
    Regulatory Expert
  • Dr Vladimir Shnaydman
    President
  • Betty Lane
    Founder and President
  • Bradley Johnson
    Owner and Principal of BN Johnson Consulting, LLC

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