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Vegas Seminar: Global Quality System

Medical device firms with multi-national facilities have many challenges. They need to create a globally harmonized quality system and use internal and supplier audits to maintain compliance with regulatory requirements. MasterControl is pleased to announce that on March 9 - 11, Compliance-Alliance, in cooperation with the University of Southern California and Underwriters Laboratories is sponsoring two seminars at the Las Vegas Westin Casuarina Hotel.

  1. Creating a Globally Harmonized Quality System (March 9 -10)
  2. Using Internal and Supplier Audits in a Globally Harmonized System (March 10 - 11)

The international faculty of 23 speakers includes senior representatives from government, industry, notified bodies, and consulting firms. The speakers have built and maintained quality systems and will share the techniques that have worked and the mistakes they have made.

1.  "Creating a Globally Harmonized Quality System" - March 9, 10

During this seminar you will learn:

  • The global requirements for quality systems
  • Challenges firms have in complying with US and international requirements
  • How to use ISO 13485 as the framework for regulatory approvals
  • Ways to create a single system throughout an international company
  • How to build a quality system that complies with US and Japanese requirements
  • Challenges for small companies
  • Steps that the international accreditation forum is taking to create a global accreditation system
  • How to implement an effective postmarket surveillance system
  • Ways to harmonize your complaint and adverse reporting system

For a complete agenda and more information, go to

2. "Internal and Supplier Auditing in a Global Quality System" - March 10 - 11

During this seminar you will learn:

  • FDA's expectations for medical device firms with international facilities
  • Best practices for conducting internal audits in international facilities
  • Techniques to get buy-in for corrective actions after an audits
  • Differences in handling an FDA inspection and a notified body audit
  • A firm and auditor's perspective on handling a inspection by the Pharmaceutical Medical Device Agency in Japan
  • How to use the GHTF guidelines for regulatory auditing of quality management systems
  • Techniques for coordinating quality compliance for suppliers
  • How to use risk management principles to prioritize your audit activities

For complete agenda and more information, go to


  • Al Taylor, FDA Center for Devices and Radiological Health
  • Robie Aridi, Vice President of Operations, Lansinoh Laboratories
  • Marlene Bobka, Vice President FOI Services
  • Kris Ann Bolt, Quality Assurance Supervisor, Harmac Medical Products
  • Denise Dion, Eduquest, formerly with FDA's Office of Regulatory Affairs
  • Cheryl Johnson, Senior Manager, International Quality, Boston Scientific
  • Tara Kambeitz, Director of Marketing, Underwriters Laboratories
  • Evangeline Loh, PhD, Director of Regulatory Affair, EmergoGroup, Inc.
  • Robert Klepinski, Fredrikson & Byron (formerly with Medtronic, Inc.)
  • Jaap Laufer, PhD, VP Public & Regulatory Affairs, Emergo Group Inc.
  • Steve McRoberts, Principal Engineer Regulatory Systems, UL
  • Jim Moore, Executive Vice President, Merrill Brink International
  • Bonnie Norman, Director RA/QA Intel Digital Health
  • C Seiko Ohyama, RCB Lead Auditor for PAL 3rd party certification, UL
  • Virginia Perry, President Perry-D'Amico and Associates
  • Frances Richmond, Ph.D, Director Regulatory Science Program, USC School of Pharmacy
  • Javad Seyedzadeh, Senior Vice President RA/QA, Gambro
  • Nancy Singer, President, Compliance-Alliance
  • Keisuke Suzuki, Former Director, Guidant Japan K.K
  • William White, Ph. D, Quality System Strategies LLC, formerly with Bayer HealthCare
  • Emi Zychlinsky, PhD, Vice President, Research and Development Hitachi Chemical Diagnostics

The cost for each seminar $1195. When registering for both seminars together, the cost is $1995.,Go to the Website for more information or  contact Nancy Singer at 703-525-4159 or


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