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Process and SOP Development for Medical Device Companies


Audio conference highlights


In order to thrive in today's economy, companies have had to "lean out" their organizations. With this push for a lean environment comes the responsibility to do things right the first time, and when issues arise and must be addressed, this must be done in a very efficient and compliant manner. This means re-engineering processes the right way.


This audio conference presentation focuses on how to create compliant yet efficient processes using 'lean compliance' techniques, which includes mapping process, determining inefficiencies and compliance gaps, with the end result being processes that are unambiguous and easy to follow. The speaker also discusses effective use of resources, employee involvement, abstract thinking, and effective change management, with the understanding that SOPs do not drive processes, processes drive SOPs.


This audio conference covers:


  • Effective process mapping techniques
  • How to drive process improvement
  • Lean compliance principles
  • Creating an effective 'mindset for change'
  • Not working in a vacuum


About the speaker:


Phil Guarino is a Managing Partner of QSN, a consulting/contracting firm specializing in quality system implementation and compliance, project management, and process improvement for regulated industries. Phil is in his 23rd year working in regulated industry, with the majority of the time spent in the medical device field. Phil has implemented and managed quality systems both domestically and internationally throughout his career. He has performed over 200 quality system audits, and has performed training in many quality disciplines. He is an approved quality trainer for multiple organizations who provide grants to firms for training.


Who should attend?


  • Quality Managers
  • VPs and Directors of Quality
  • Plant Managers
  • Process Engineers
  • Quality Engineers


Product Details

Phil Guarino, Quality Solutions Now (QSN)
Process and SOP Development for Medical Device Companies
Title: Managing Partner
Duration: 60 minutes
Event Type: Previously recorded on 2010-08-18
Item #: ac20100818b
18 Aug 2010 
Registration Price:
$249.00

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