FDAnews Announces — ISO 13485:2016 – Preparing for Implementation Webinar, Aug. 18, 2016

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How will QSR, QMS, MDSAP be affected by ISO 13485:2016? Join industry expert Dan O’Leary, President of Ombu Enterprises, LLC, on Aug. 18 for the ISO 13485:2016 — Preparing for Implementation webinar when he illustrates the revisions and explains the transition plans for the certificates from the current versions (ISO 13485:2003 and EN ISO 13485:2012) to the corresponding new versions(ISO 13485:2016 and EN ISO 13485:2016).

ISO 13485:2016 – Preparing for Implementation
**An FDAnews Webinar**
Aug. 18, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/iso13485-2016        

QSR… QMS… MDSAP… How will these be affected by ISO 13485:2016?

What does it mean for corrective and preventative action? Design control? Risk management? Supplier management?

Join industry expert Dan O’Leary, President of Ombu Enterprises, LLC, on Aug. 18 for the ISO 13485:2016 — Preparing for Implementation webinar when he illustrates the revisions and explains the transition plans for the certificates from the current versions (ISO 13485:2003 and EN ISO 13485:2012) to the corresponding new versions(ISO 13485:2016 and EN ISO 13485:2016). Additionally, he’ll point out potential conflicts with the QSR.

In 90 minutes, attendees will learn:

  •     The transition plan for certificates
  •     The transition plan for the EU Harmonized Standard
  •     The role of ISO 13485:2016 in the MDSAP and Canada’s plan to adopt it
  •     The major differences between ISO 13485:2003 and ISO 13485:2016
  •     The status of supporting documents such as ISO 9000:2015 and ISO/TR 14969:2004
  •     The status of EN ISO 13485:2016 and issues related to the product directives
  •     Some potential concerns related to ISO 13485:2016 and the FDA’s QSR

BONUS MATERIAL: Attendees will receive a comparative analysis of the changed requirements in ISO 13485:2016. It will identify ISO13485:2003 requirements and show the additions and deletions resulting from ISO 13485:2016.

Register today and begin preparing for implementation of ISO 13485:2016.

Meet the Presenter:
Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

Who Will Benefit:
Creating the procedures, developing the records, and ensuring compliance is a team effort involving many functions and disciplines. This includes people in the following roles:

  •     Quality Managers
  •     Quality Engineers
  •     Quality Auditors
  •     Regulatory Managers
  •     MDR Handling Specialists
  •     Complaint Handling Specialists
  •     Risk Managers
  •     Data Analysts

Webinar Details:
ISO 13485:2016 – Preparing for Implementation
Aug. 18, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/iso13485-2016        

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/iso13485-2016                    
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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