FDAnews Announces — Auditing for Medical Device Manufacturers: Create Successful Audit Programs Sept. 10-12, 2019, Philadelphia, PA

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Devicemakers! Learn to plan and implement effective audit programs: identify/resolve challenges, make informed supplier choices in US, EU.

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Auditing for Medical Device Manufacturers:
Create Successful Audit Programs
**Interactive Workshop Series from FDAnews and Ombu Enterprises**
Sept. 10-12, 2019 • Philadelphia, PA
https://www.fdanews.com/auditingmd

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

In the two-day training (Sept. 10-11), Ombu Enterprises’ Dan O’Leary — one of FDAnews’ most sought-after trainers — will teach attendees how to create a compliant, efficient and effective auditing program. He will give attendees interactive exercises with real-life case studies attendees will work through to put new knowledge into practice. Attendees 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

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

If ones organization does any business in the EU, this one-day workshop will be vital. One will get the information needed to integrate a Notified Body (NB) EU-MDR audit into internal quality programs. Attendees 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.

Gain the direct, hands-on training to need to comply with regulators’ requirements and expectations. Space is limited… Reserve a seat today.

Webinar Details:
Auditing for Medical Device Manufacturers:
Create Successful Audit Programs
**Interactive Workshop Series from FDAnews and Ombu Enterprises**
Sept. 10-12, 2019 • Philadelphia, PA
https://www.fdanews.com/auditingmd

Tuition:
Early Bird Pricing: $1,597 (available until April 9, 2019)
Regular Pricing: $1,797 (after April 9, 2019)
Significant team discounts are available.

Easy Ways to Register:
Online: https://www.fdanews.com/auditingmd
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative,
and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Contact Author

Michelle Butler
FDAnews
703-538-7600
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