CAPA Challenges and FDA Expectations by davidross759

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Expectations for meaningful, results driven CAPA (Corrective and Preventive Action) System that addresses and resolves underlying product problems are increasing among regulatory agencies worldwide, with good reason. EU’s ISO 14971 (Device Risk Management) and the FDA's QSIT and Q9, underscore this increased emphasis. A valid closed-loop CAPA system utilizes root cause analysis for true problem (not symptom) resolution. Growing highprofile field problems indicate that effective "closed loop" CAPA is still not the industry norm. The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop CAPA, an integral part of viable Quality Management / cGMP planning, implementation and execution systems

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    Live Webinar            on
 
        CAPA Challenges and FDA Expectations

    Date & Time:                                                                                                                         

        Wednesday, July 27, 2011           10:00 AM PDT | 01:00 PM EDT
                                                                                                    Register Now                            
        Duration: 90 Minutes               Instructor: John E Lincoln

        Location: Online                   Price : $245.00   (for one participant)

                                                                                              Instructor Profile:

        Why you should attend:
                                                                                                           John E Lincoln
    Expectations for meaningful, results driven CAPA (Corrective and                                  Consultant, Medical device
    Preventive Action) System that addresses and resolves underlying                                    and Regulatory Affairs
    product problems are increasing among regulatory agencies
    worldwide, with good reason. EU’s ISO 14971 (Device Risk                                  John E. Lincoln is a medical device
    Management) and the FDA's QSIT and Q9, underscore this increased                          and regulatory affairs consultant. He
    emphasis. A valid closed-loop CAPA system utilizes root cause                             has helped companies to implement
    analysis for true problem (not symptom) resolution. Growing high-                         or modify their GMP systems and
                                                                                              procedures, product risk
    profile field problems indicate that effective "closed loop" CAPA is still
                                                                                              management, U.S. FDA responses.
    not the industry norm. The billions of dollars spent by industry
                                                                                              In addition, he has successfully
    annually on quality / GMP are not providing the product safety or                         designed, written and run all types of
    efficacy seemingly promised. And for most companies, the fixes are                        process, equipment and software
    not rocket-science, but proper up-front risk-based, closed-loop CAPA,                     qualifications/validations, which have
    an integral part of viable Quality Management / cGMP planning,                            passed FDA audit or submission
    implementation and execution systems.                                                     scrutiny, and described in peer-
                                                                                              reviewed technical articles, and
                                                                                              workshops, world wide. John has
        Areas Covered in the Session:                                                         also managed pilot production,
                                                                                              regulatory affairs, product
                                                                                              development/design control, 510(k)
          l   Regulatory "Hot Buttons"
                                                                                              submissions, risk management per
          l   CAPA Background
                                                                                              ISO 14971, and projects; with over
          l   Correction, Corrective Action, Preventive Action Defined                        28 years of experience in the FDA-
          l   Impact Analysis and Response - a Key Component                                  regulated medical products industry
          l   CAPA System Assessment                                                          - working with start-ups to Fortune
          l   Data Sources / Metrics                                                          100 companies, including Abbott
          l   Monitor for Effectiveness                                                       Laboratories, Hospira,
                                                                                              Tyco/Mallinckrodt. He is a graduate
          l   Lock In the Change - Close the Loop
                                                                                              of UCLA. ...more
          l   Beyond Regulatory Compliance


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        Who Will Benefit:                                                                      Your Necessity is our Priority


          l   Senior management in Drugs, Devices, Biologics, Dietary
              Supplements
          l   QA
          l   RA                                                                                                
          l   R&D
          l   Engineering
          l   Production
          l   Operations
          l   Consultants; others tasked with product, process, CAPA
              resolution, failure investigation responsibilities


     
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