ISO, FDA, or any quality system audit can be about as nerve-wracking as going to the dentist. Worse, really, because so much is at stake. But what if you had a better sense of what your auditors might probe for and know just how far they will dig?
Steve Gompertz, CMQ/OE, CMDA, RAC-US, CMII, shares his expert advice based on 30 years of experience on how to prepare for and conduct your next audit with total confidence. Expect practical insights — sprinkled with humor — to make your next audit less of a thriller and more of a smooth ride as he reveals what quality system auditors are really looking for.
Attendees will take away:
- Auditor objectives
- Effective audit preparation
- Do’s and don’t’s during an audit
- Insights into common audit pitfalls
- Strategies for engaging with auditors
- Tips for managing auditors’ expectations
- Preparation tactics beyond surface cleaning
Steve is a leader in Quality Systems management with over 30 years of experience in the medical technology industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Vital Images, and Control Data. He is now a consultant to the medical technology industry, providing guidance on quality systems and regulatory compliance.
Steve holds a B.S. in Mechanical Engineering from Lehigh University and certifications in quality management, medical device auditing, regulatory affairs, project management, and configuration management. Steve started his professional career in software development and then moved into systems implementation project management. After joining the medical device industry, he transitioned from implementing quality-related IT solutions to managing quality organizations and processes. Steve also helped St. Cloud State University develop and is a Sr. Adjunct Instructor in the “M.S. in Medical Technology Quality” program. In 2023 he was named a Distinguished Speaker by the Society for Quality Assurance (SQA) and awarded the Charles W. Britzius Distinguished Engineer Award by the MN Federation of Engineering, Science, and Technology Societies (MFESTS).
