Auditing Analytical Laboratories for FDA Compliance - Webinar By GlobalCompliancePanel

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					                                                                       Toll Free Number: 800-447-9407


                                                                           RAPS Approved Webinar on


Auditing Analytical Laboratories for FDA Compliance

Date: Wednesday, November 28, 2012                                      Time: 10:00 AM PST | 01:00 PM EST

Course "Auditing Analytical Laboratories for FDA                Duration:       90 Minutes
Compliance" has been pre-approved by RAPS as
                                                                Instructor:     Steven S Kuwahara
eligible for up to 1.5 credits towards a participant's
RAC recertification upon full completion.                       Location:       Online


                      Steven S Kuwahara
                      Founder & Principal, GXP                               Register Now
                      Biotechnology, LLC

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that
works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30
years of experience in supervising quality control laboratories, ...more


Overview:
Auditing analytical laboratories can be complex because of the preparation that is often required.
All of the GMP rules do not apply to the laboratory; while there may be additional requirements
depending upon the type of testing that is being conducted. In many cases, the laboratory itself
may not understand what regulations apply to the work that is being conducted. This presentation
will discuss what advance preparation is needed on the part of the auditor, and discuss what the
auditor should look for during the audit. Since documentation is often an issue, a discussion of
documentation problems will be presented.


Areas Covered in the Session:

    l   GMP regulations that apply to analytical
        laboratories.
    l   Reviewing documentation
    l   Advance preparation for the audit
    l   Auditing styles and structures
    l   Equipment and laboratory instrument qualification.
    l   What to look for while doing a walk-through.
    l   Other regulations and standards, including ISO
        17025
    l   Following through on the audit


Who Will Benefit:

    l   External and Internal
        Auditors                           Suggest a Topic
    l   Supervisors and Analysts
        in Quality Control                 More Webinars
        Laboratories and Quality
        Assurance groups.
    l   Supervisors and Analysts
        in Contract Testing
        Laboratories                       Click here to
    l   Personnel Responsible for        register for this
        Selecting Contract Testing            webinar
        Laboratories
    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
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DOCUMENT INFO
Description: Overview: Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted. This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be presented.