Education

Education

ASQ Worcester Course Offerings Reminder

Past Meetings

  • June Meeting Wrap-up

    John Conner, ASQ Region 1 Director, provided information and insight on how to get the most out of our ASQ Membership.  The focus of any ASQ Section is to provide Member Value to the section membership.  If you have any thoughts or ideas on how we can provide more value to you, please contact any one of the Leadership Team Members listed in the Contacts page.  We welcome your suggestions and ideas.

  • September Meeting Wrap-up

    September 21, 2017 dinner meeting speaker, Connie Hoy is a regulatory professional with 30 years’ experience in medical devices. Connie is the Executive VP of Clinical Development and Regulatory Affairs for Cynosure, Inc., the global leader in the medical laser industry.

    Connie did an outstanding job by communicating her journey of getting ready for the audit and how the audit was conducted. A checklist prepared by the Notifying body was used step by step to conduct the audit with planned times. Employees had to be well prepared with information to answer questions. A point system is used in the MDSAP audit for identifying minor or major non conformances.

    Two facilities, in MA & NY, were audited and passed with only minor findings. Connie was delighted to answer questions and took business cards to send information on MDSAP. If you are making Medical Devices, it will be worthwhile to look into this audit program since it covers FDA and 5 other countries. This will reduce audits and enhance your quality system.