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Creating Successful Medical Device Audit Programs: Sept. 10-11, 2019
Implementing Effective EU-MDR Audit Programs: Sept. 12, 2019

While an effective and efficient audit program will reap enormous rewards for device manufacturers, creating and conducting a comprehensive, well-organized program is far from simple. Add in ISO 19011:2018, FDA QSR, ISO 13485:2016, and regulators’ use of FDA’s QSIT, the IMDRF MDSAP Audit Model, and regional requirements such as EU-MDD and EU-MDR… it is enough to prompt a devicemaker’s head to spin.

In this hands-on two-day training (Sept. 10-11), Ombu Enterprises’ Dan O’Leary – one of FDAnews’ most sought-after trainers — will teach you how to meld these sources into one compliant, efficient and effective auditing program. He will give you interactive exercises with real-life case studies you will work through to put your new knowledge into practice. You will:

  • Understand the concepts of management system auditing
  • Learn the differences among First-Party, Second-Party and Third-Party Audits
  • Learn the differences among system audits, process audits and product audits
  • Learn how to establish and implement an audit program
  • Understand the differences between QSR and ISO 13485:2016 audit requirements
  • Learn how FDA classifies inspections and the results
  • Learn how the MDSAP program classifies audit nonconformances
  • Understand the underlying concepts in audit sampling plans
  • Learn how to report audit results
  • Understand the principles of auditor competence and evaluation

Space is limited for this hot topic, so register today.

Special Third-Day Add-On:
Implementing Effective EU-MDR Audit Programs

With just one additional day, you will learn to conduct effective internal audits of the new EU-MDR requirements, including good audit practices, an understanding of the Notified Body’s (NB) audit expectations, and how to integrate an NB EU-MDR audit into your internal quality program as well as how to prepare for the NB audit.

During the course of this hands-on, interactive workshop, you will:

  • Understand the conformity assessment paths in the EU-MDR based on device class
  • Understand the initial NB auditing requirements in each conformity assessment annex
  • Review the surveillance NB auditing requirements
  • Understand the NB QMS requirements for Annex VII
  • Learn the specific Annex VII areas in the initial audit
  • Learn the NB auditor qualifications from Annex VII
  • Learn how to map the NB audit approach to the medical device auditing program

This add-on workshop assumes a basic familiarity with the EU-MDR and with quality auditing. Attending the previous day’s workshop (Sept. 10-11) is recommended but not required to attend this (Sept. 12) day.

If you do business in the EU, this add-on cannot be missed. Space is limited, so… Reserve your seat TODAY.