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      ASQ Biomedical presents Audit Avalanche in Santa Clara

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      October 22, 2013 - October 23, 2013

      Tuesday   8:30 AM - Wednesday 4:30 PM

      2151 Laurelwood Road
      Santa Clara, California 95054

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      EVENT DETAILS
      ASQ Biomedical presents Audit Avalanche

       

      Back by popular demand, with even more informative talks than last time!

      __AUDIT AVALANCHE___

      Presented by: ASQ Biomedical Division

      Are you managing the audits of your quality system or have the different types of audits got you buried? Are your audits a ‘smoking gun’? Are you trending and reacting to the results in a value added way? Does your audit program include the new ISO 14971 risk requirements?

      Come and benchmark your Audit processes and techniques against those of experts and dig yourself out of the auditing hole. Learn how you can reduce the time to prepare for your audits and maximize your audit experience and reach successful new heights.

      WHEN:     October 22 & 23, 2013

      WHERE:  Hotel Biltmore, 2151 Laurelwood Road, Santa Clara, CA 95054

                      Click on direct registration for Hotel Biltmore below              

      https://reservations.ihotelier.com/crs/g_reservation.cfm?groupID=1094165&hotelID=13370

       

      TIME:       8:30 AM- 4:30 PM Day 1, 8:30 Am - 4:30 PM Day 2 (Registration at 8:00 AM)

      This 2 day seminar will provide an update of the current trends and practices associated with auditing from Internal Audits to FDA/Notified Body Audits.  Details and descriptions of topics at the end of this page.

       

      Brazil ANVISA Audits, Brendan Corbin

      Clinical Audits, Carol Houts

      Combination Product Audits, David Manalan

      FDA Inspections, Elaine Messa

      IEC 60601 Notified Body Inspections, Scott Blood

      Internal Audits, Beth Kelly

      ISO 13485 and CMDR Audits, Debbie Iampietro

      ISO 14971 & MDD requirements, David Manalan

      Japan PAL Audits, Richard Vincins

      Management Responsibility & Trending, Mary Getz

      Sterilization Services Audits, Debbie Iampietro

      Supplier Audits, John Freije

      Computer System Auditing, Bill Kurani

       

      Cost per person, including lunch and thumbdrive with presentation $499

      For additional information or questions contact
      Beth Kelly at Beth@Kellyqc.com or Pam Goldstein at pgoldstein.qa@gmail.com

       

      Event Refund Policy: We unfortunately cannot offer refunds for cancellations made within 2 weeks of this event. Substitute or replacement persons are permitted.

      For more information about ASQ Biomedical Division go to www.asq.org/biomed

       

      DETAIL:

      Internal Audits Planning, executing, collecting objective evidence, constructing nonconformances, auditor credentials, checklists and more.   For the more experienced participants, this talk will focus on Best Practices.

      Beth Kelly, Principal Consultant Kelly Quality & Compliance,
      Program Chair ASQ Biomedical & Chair Elect New England DG

       

      Supplier Audits – Conducting meaningful supplier audits - when to audit, what audit methods may be used and how to utilize your own resources for the most effective outcome

      John Frieje, Prinicpal Consultant Frieje Engineering

       

      Notified Body Audits & CMDR Review of the Notified Body approach as well as recent hot topics. Focus is on the regulatory requirements of the audit as it relates to ISO 13485. Understanding of the audit techniques of Notified Bodies and how to respond to the audit Major and Minor Nonconformances.    

      Debbie Iampietro, President QRC Consulting, UL Certified Auditor

       

      Japan PAL Audits Understand the focus of a PAL audit and develop a strategy for a successful audit. PAL audits are different and preparation and alignment of needs is key.

      Richard Vincins, Vice President QA Emergo

       

      Brazil ANVISA Audits How to arrange, handle and close the audit for success. Tips on how to best work with interpreters for audit success.

      Brendan Corbin, Quality Engineering Manager, NeuroTherm

       

       

      Auditing Sterilizers and Sterilization Supporting Documentation. What to look for at the Gamma or ETO sterilizer.   How to ensure that you have the required supporting documentation to support revalidation, quarterly dose audits and more.

      Debbie Iampietro, President, QRC Consulting, UL Certified Auditor

       

      FDA Audits - How to prepare for an announced/unannounced FDA audits. How to prepare the back room/ front room for best audit control and how to respond to the audit observations. Tips and tricks to represent you as prepared.

      Elaine Messa, President, Becker & Associates Consulting

       

      EN ISO 14971 and the MDD What is now required to meet the Essential Requirements? What does 14971 require and what does the EU require? What happens when the Directives all get revised?

      David Manalan, President, INQC Consulting, Inc.  

       

      Combination Products Auditing provide auditors with a strong foundation for auditing combination product by:

      • dissecting the Current GMP Requirements for Combination Product Final Rule,
      • summarizing current guidance and policy surrounding combination product GMP's,
      • comparing and contrasting the US and EU approach to combination products and the assessing the impact on the auditing process, and
      • reviewing the cultural differences in the two regulatory approaches for the purpose of helping the auditor focus on the facts and requirements.

      David Manalan, President, INQC Consulting, Inc.

       

      Clinical Audits Clinical quality audits are an extremely effective tool in securing quality clinical trials and GCP conformance. Strategies will be presented to support the implementation of an effective clinical audit program.

      Carol Houts, President, Clinartis

       

      Management Responsibility & Trending   Are your audits a smoking gun? Realize the value of Management Review as an opportunity. Take the lesson learned from your internal audit program and look at other areas where similar types of problems may lie. Additionally, how to take those findings and establish metrics that will enable you to be more proactive in nature.  

      Mary Getz, PhD, VP of Medical Device Quality Systems, Becker & Associates

       

      ISO 60601 Inspections For medical device manufacturers who have designed or are producing Medical Electrical Equipment (MEE) and require certification of compliance to IEC 60601-1:2005 Third Edition, routine factory inspections are performed by the certification body. Learn what the goal of this inspection as, what the inspectors are looking for and how to handle ISO60601 inspections.

      Scott Blood, Senior Director, Quality Assurance, Nine Point Medical

       

      Computer Systems: Software/Hardware Auditing based on FDA regulations and ISO standards.
      The presentation provides medical device manufactures and auditors with a strong foundation for auditing software product by:

      • Dissecting the FDA Title 21 CFR Part 11 regulations requirements and ISO 62304 Software Life Cycle Standards.
      • Summarizing software types, categories, standards and regulations
      • Provide guidance on software audit scope either limited to one of the software life cycle process activity or for complete software life cycle process.
      • Audit based on risks associated with the use of software.
      • Guidance on software audits scope based on software type like medical device software, purchased or customized automation software, software as a service etc.
      • Auditing IT Infrastructure based on ISO 27001 Information Technology Security.Standards
      • What information to look for in the software life cycle procedure during the audit?
      • How to avoid ISO audit and FDA inspection observations?

      Bill Kurani, MSRA, MSEE, Directory of Regulatory Affairs and
      Quality Assurance at Natera, Inc

      Categories: Other & Miscellaneous

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.
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