ASQ Biomedical presents Audit Avalanche
Oct 22 2013 - Oct 23 2013
8:30 AM - 4:30 PM
San Diego Junior Chamber Of Commerce
2151 Laurelwood Road
Santa Clara, CA 95054
Back by popular demand, with even more informative talks than last time!
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
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
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
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:
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:
Bill Kurani, MSRA, MSEE, Directory of Regulatory Affairs and
Quality Assurance at Natera, Inc