FDAnews Announces — Inspections Summit Preview: Recertification Audits — Don’t Let Your Devices Lose Their CE Mark Webinar, Sept. 25, 2015

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Having a facility certified to produce medical devices for sale in Europe is only the first step. Regulations newly in force say the Notified Body must audit devicemakers at least once every three years, and these audits will focus less on the facility and more on the devices themselves.

Inspections Summit Preview:
Recertification Audits — Don’t Let Your Devices Lose Their CE Mark
**FDAnews Webinar**
Sept. 25, 2015 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/inspectionssummitpreview

Having a facility certified to produce medical devices for sale in Europe is only the first step. Regulations newly in force say the Notified Body must audit devicemakers at least once every three years, and these audits will focus less on the facility and more on the devices themselves. These audits are unannounced and, depending on size, could take anywhere from a few days to several weeks. If a manufacturer fails one, they’ll be at risk of having their devices lose their CE mark, meaning manufacturers be barred from selling them in the EU until the problem is corrected.

Things to know:

  •     Who TÜV, DEKRA and BSI are and why manufacturers should be working with one of them?
  •     Whether each device is classified as I, IIA, IIB, or III?
  •     Which classes will require a design dossier or a technical file?
  •     The difference between horizontal and vertical standards?
  •     Which of those standards apply to each device, and the last time they were updated?
  •     The specific kinds of objective evidence auditors will expect to see?
  •     What factors could lead to more frequent audits?

If a manufacturers can’t give a confident “yes!” to every one of those questions, Roberta Goode’s webinar will provide the answers they need. Don’t risk having costly obstacles come between the devices and the European market.

This webinar is just a sample of the valuable information attendees will learn from Ms. Goode and many other speakers at FDAnews’ Tenth Annual FDA Inspections Summit on Nov. 4-6, 2015 in Bethesda, MD. Register to experience it and FDAnews will deduct the cost of the webinar from the Inspections Summit registration!

Meet the Presenter:
Roberta Goode
President and CEO, Goode Compliance International

Roberta Goode is an executive with over 25 years of experience in the medical device industry. She is currently President and CEO of Goode Compliance International (GCI), a global leader in engineering and compliance services for medical device manufacturers, specializing in process validation, design control, and risk management. Prior to founding GCI in 2002, Ms. Goode held positions of increasing responsibility in R&D, Manufacturing, and Quality Engineering at Beckman-Coulter Corporation, Althin Medical, Inc. (acquired by Baxter Healthcare), and Cordis Corporation (a Johnson & Johnson company), where she contributed intellectual property in the form of four U.S. patents for percutaneous cardiovascular interventional devices. She holds a Master of Science degree in Biomedical Engineering and a Bachelor of Science degree from the University of Miami. Additionally, Ms. Goode has an adjunct faculty appointment at the University of Miami’s College of Engineering and is an ASQ Certified Quality Engineer.

Who Will Benefit:

  •     Auditors
  •     Compliance officers
  •     Engineering and design controls teams
  •     Executive management
  •     General/corporate counsel
  •     Investigators
  •     Managers
  •     Manufacturing directors and supervisors
  •     QA/QC personnel
  •     R&D staff
  •     Regulatory/legislative affairs professionals
  •     Risk management specialists
  •     Training personnel
  •     Validation specialists, scientists, engineers

Conference Details:
Inspections Summit Preview:
Recertification Audits — Don’t Let Your Devices Lose Their CE Mark
**FDAnews Webinar**
Sept. 25, 2015 — 11:00 a.m. – 12:30 p.m. EDT
http://www.fdanews.com/inspectionssummitpreview

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/inspectionssummitpreview
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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Michelle Butler
FDANEWS
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