Docstoc

Validation and 21 CFR Part 11 Compliance of Computer Systems

Document Sample
Validation and 21 CFR Part 11 Compliance of Computer Systems Powered By Docstoc
					                                                                                                                               


    2-day In-person Seminar on
 
     Validation and 21 CFR Part 11 Compliance of Computer Systems

    RAPS Approved. Earn 12 RAC Points                                                                                           


    Date & Time:                                                                            Register Now                        

     May 03rd and May 04th 2012          9 AM PDT to 5 PM PDT

     Duration: 2 Days                    Instructor: Angela Bazigos
                                                                                       Instructor Profile:
                                         Price : $1695.00   (for one
     Location: San Francisco
                                         participant)
                                                                                                  Angela Bazigos
                                                                                                  CEO, Touchstone
                                                                                              Technologies Silicon Valley
    Overview:
    In December 2010 the FDA changed the way it does audits to include                 Angela Bazigos is the CEO of
    21 CFR 11 add-on inspections. Very little is known about this, yet the             Touchstone Technologies Silicon
    FDA has already issued citations on the subject. This Webinar will                 Valley, Inc. an FDA Compliance
    present the latest on FDA thinking (with slides directly from the FDA's            company. She has almost 30 years
    Office of Compliance), discuss how these inspections will impact both              experience in the Lifesciences
                                                                                       industry and has applied for patents
    your company an the industry, and provide guidance on how your
                                                                                       aimed at speeding up Software
    company can ensure that they have a successful inspection.
                                                                                       Compliance. She is a member of the
                                                                                       SQA CVIC (Society of Quality
    Interactive course to cover all areas of 21 CFR 11 and how to include              Assurance Computer Validation
    21 CFR 11 requirements in computer systems validation. Will include                Initiative Committee), DIA and RAPS
    exercises where the attendees will build all the deliverables for a                and teaches classes on 21 CFR 11,
    computer system using the 21 CFR 11 principles and requirements.                   Computer Systems Validation,
    Finally, a fun ‘Jeopardy’ quiz will be used to test the participants’              Compliance Strategy and Project
                                                                                       Management. More recently, Ms.
    knowledge
                                                                                       Bazigos was selected to co-author
                                                                                       Computerized Systems In Clinical
                                                                                       Research / Current Data Quality and
    Areas Covered in the Session:                                                      Data Integrity Concepts with FDA,
                                                                                       DIA and Academia. ...more

    Day 1, May 3rd, 2012

    Lecture 1: Introduction to 21 CFR 11                                              Suggest a Topic       More Webinars

                                                                                        Your Necessity is our Priority
       l   History of 21 CFR 11
       l   Current Status of 21 CFR 11
       l   21 CFR 11 Overview
       l   21   CFR   11.10 (a)-(k)
       l   21   CFR   11.30
                                                                                                         
       l   21   CFR   11.50
       l   21   CFR   11.70
       l   21 CFR 11.100
       l   21 CFR 11.200
       l   21 CFR 11.300
       l   The FDA’s Requirements for 21 CFR 11
       l   FDA’s Add-On Inspections for 21 CFR 11                              


    Lecture 2: 21 CFR 11.10 (a) Computer Systems Validation
    Deliverables


       l   Risk Assessment
       l   Vendor Audit
       l   Validation Plan
       l   Requirements Specification
       l   Design Specification


    Day 2, May 4rd, 2012

    Lecture 3: 21 CFR 11.10 (a) Computer Systems Validation
    Deliverables


       l   Installation Qualification (IQ)
       l   Operational Qualification (OQ)
       l   Performance Qualification (PQ)
       l   Traceability Matrix
       l   Validation Summary Report
       l   Validation Registry
       l   SOPs
     l   21 CFR 11 Audit


 Lecture 4: 21 CFR 11.10 (A) Computer Systems Validation
 Deliverables Exercise


     l   Create ALL Deliverables for a Laboratory Information
         Management System (LIMS)
     l   Jeopardy - Test Your Knowledge


 Click here to register for this webinar


  Who Will Benefit:

     l   Directors
     l   Managers
     l   Supervisors, and lead workers in Regulatory Affairs
     l   Quality Assurance and Quality Control
     l   Workers who will prepare GMP documents for early phase
         products as well as those who will review these documents
     l   Regulatory affairs workers who will need to deal with
         submissions covering early phase products.



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


If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

				
DOCUMENT INFO
Description: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company an the industry, and provide guidance on how your company can ensure that they have a successful inspection.