Speaking Engagements

ASQ, Las Vegas Section:

  • An Effective CAPA System for Medical Device Manufacturers
  • Transitioning from ISO 9001:2008 to ISO 13485:2003–Going After the Medical Device Business

 

ASQ, Palomar Section (Southern CA):

  • Major, Minor, or Is it Just the Auditor’s Opinion–Writing Clear and Concise Audit Nonconformities (and How to Defend Them)
  • ISO 9001:2015 Roundtable Discussion
  • FDA Inspections vs. Quality System Audits—Know the Differences

 

Institute of Validation Technology Medical Device Workshops:

  • Post Market Surveillance: Why Complaints Aren’t (Usually) Enough

 

MD&M West Conference:

  • CAPA—Common Pitfalls and How to Avoid Them
  • Documentation Management for the Medical Device Industry (co-presenter)

 

Medical Product Development certificate program, UC-Irvine Extension:

  • Quality System Regulations 21 CFR Part 820

 

Northern California Discussion Group, ASQ Biomedical Division:

  • EN ISO 13485:2003, Process Based Approach

 

SDRAN Medical Device Conference:

  • Canadian Medical Device Conformity Assessment Systems

 

SDRAN RAC Study Groups:

  • Medical Device Regulations 21 CFR Part 803, 820

 

IEEE PSES (Product Safety Engineering Society) San Diego Chapter:

  • An Overview of ISO 13485:2016

 

Del Mar CA Electronics and Manufacturing Trade Show:

  • Thinking of Implementing ISO 13485:2016? A Look at the  Requirements