FDAnews Announces — ISO 13485: What’s New and How It Affects You Webinar, May 16, 2016

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After many years of the same old, same old ISO 13485, the first major revision to the standard has been introduced. Who better to explain the new requirements than Kim Trautman — Executive Vice President, NSF Health Sciences, Medical Device International Services — and former Associate Director, International Affairs Office of CDRH?

ISO 13485:
What’s New and How It Affects You
May 16, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/ISO13485        

After many years of the same old, same old ISO 13485 — the first major revision to the standard has been introduced. Do manufacturers know 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?

Who better to explain the new requirements than Kim Trautman — Executive Vice President, NSF Health Sciences, Medical Device International Services — and former Associate Director, International Affairs Office of CDRH?

Join Kim on May 16 for a 90-minute webinar and:

  • Hear about the fundamental changes and why the requirements were revised
  • Understand the change of the standards scope
  • Understand the transition period for the new standards and how that must be planned for now
  • Hear about the new ISO 13485 Handbook as the replacement for the TR14969

Register today to gain a comprehensive understanding of the new ISO 13485 standard.

Meet the Presenter:
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.

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:
What’s New and How It Affects You
May 16, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/ISO13485        

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/ISO13485        
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
+1 (703) 538-7665
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