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Bullet-Proof Closed-Loop CAPA - Webinar By GlobalCompliancePanel

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Bullet-Proof Closed-Loop CAPA - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                   Phone: 800-447-9407


                                                                      RAPS Approved Webinar on


Bullet-Proof Closed-Loop CAPA

Date: Wednesday, October 31, 2012                                    Time: 10:00 AM PDT | 01:00 PM EDT


                                                                 Duration: 90 Minutes
Course "Bullet-Proof Closed-Loop CAPA" has been
pre-approved by RAPS as eligible for up to 1.5                  Instructor: John E Lincoln
credits towards a participant's RAC recertification               Location: Online
upon full completion.
                                                                     Price : $245.00 (for one participant)


                    John E Lincoln
                    Consultant, Medical device                           Register Now
                    and Regulatory affairs,

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to
implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.
...more


Overview:
CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in
product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk
management and mitigation activities.

A compliant CAPA system is required to to "close-the-loop" complaints, non-conformances, out-of
specification conditions, and must include proper impact analysis / actions. As such CAPA is a major
element of cGMP compliance (one of the four key inputs of QSIT, the FDA's Quality Systems
Inspection Technique), and is also a key source of regulatory problems. How can companies
allocate scarce resources to those activities that have the greatest impact to product quality /
safety, minimize resources on minor issues, and still satisfy the regulatory agencies? Use the CAPA
system not just to satisfy regulatory requirements, but to facilitate a closed-loop problem resolution
system to reduce "fire fighting" and minimize costly product quality problems.



Areas Covered in the Session:

    l   Regulatory "Hot Buttons"
    l   CAPA Background
    l   Correction, Corrective Action, Preventive Action
        Defined
    l   Impact Analysis and Response - a Key Component
    l   CAPA System Assessment
    l   "Bullet-Proof"
    l   Data Sources / Metrics
    l   Monitor for Effectiveness
    l   "Closed-Loop" - Lock In the Change
    l   Beyond Regulatory Compliance



Who Will Benefit:

    l   Senior Management in             Suggest a Topic
        Drugs, Devices, Biologics,
                                          More Webinars
        Dietary Supplements
    l   QA
    l   RA
    l   R&D
    l   Engineering                      Click here to
    l   Production
                                       register for this
    l   Operations
    l   Consultants                         webinar


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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DOCUMENT INFO
Description: CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities.