FDAnews Announces — ISO 13485:2016 — Design Specifications and Preparing for Implementation: A 2 Part Series On-Demand Webinar, Dec. 20, 2016

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It’s been a big year for ISO 13485. FDAnews held two ISO 13485 related webinars earlier this year and want to give manufacturers another opportunity to hear the Kim Trautman and Dan O’Leary hosted webinars for the price of one.

ISO 13485:2016 — Design Specifications and Preparing for Implementation:
A 2 Part Series
**An FDAnews On-Demand Webinar**
Part 1 – Design Specifications: Dec. 20, 2016 ∙ 11:00 a.m. - 12:30 p.m. ET
Part 2 – Preparing for Implementation: Dec. 20, 2016 ∙ 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/iso13485ondemand        

It’s been a big year for ISO 13485. FDAnews held two webinars earlier this year and wants to give manufacturers another opportunity to hear them in case they missed it the first time around. Listen to both webinars for the price of one.

After dozens of years of the same old, same old ISO 13485 the first major revision to the standard has been introduced. What are the ins and outs of it?

Will the requirements really be consistent with current cGMP and quality system requirements?

What is the bottom line impact on CAPA, supply chain, adverse event reporting, environmental controls and complaint handling?

FDAnews has compiled the most comprehensive presentations on the subject. Who better to explain the new requirements in Part 1 than Kim Trautman, Executive Vice President, NSF Health Sciences, Medical Device International Services and former Associate Director, International Affairs Office of CDRH.

In Part 2 medical device regulations and standards expert, Dan O’Leary, president of Ombu Enterprises, will break down the standard line-by-line and explain everything manufacturers need to know to be fully prepared.

Attendees will be able to understand:

  •     The consistencies and inconsistencies with other documents in the ISO family
  •     The common elements of the standard that can be implemented by organizations without unnecessary duplication
  •     Specific areas impacted by the revised standard
  •     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 to gain the most comprehensive understanding of the new ISO 13485 standard.

Please note; these webinars were previously recorded and no questions will be taken during the presentation.

Meet the Presenters:
Kimberly Trautman
Executive Vice President, NSF Health Sciences, Medical Device International Services
Kim Trautman has more than 30 years of experience in medical device quality systems and international regulatory affairs. She is focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program. Ms. Trautman previously worked for the FDA’s CDRH where she led the CDRH’s international efforts and initiatives. She was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs and led continuing harmonization efforts with ISO 13485.

Dan O’Leary, President, Ombu Enterprises, LLC
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:

  •     Quality Managers
  •     Quality Engineers
  •     Quality Auditors
  •     Regulatory Managers
  •     Design & Development Managers
  •     Design Engineers
  •     Production Managers
  •     Production Supervisors
  •     Manufacturing engineers
  •     Members of the transition team

Webinar Details:
ISO 13485:2016 — Design Specifications and Preparing for Implementation:
A 2 Part Series
**An FDAnews On-Demand Webinar**
Part 1 – Design Specifications: Dec. 16, 2016 ∙ 11:00 a.m. - 12:30 p.m. ET
Part 2 – Preparing for Implementation: Dec. 16, 2016 ∙ 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/iso13485ondemand        

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/iso13485ondemand        
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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