FDAnews Announces: Understanding ISO 19011:2018 -- The Path to Better Medical Device System Audits Webinar, Oct. 30, 2018

Thursday, October 11, 2018 General News
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ISO 19011 is the rulebook for creating a device quality management system (QMS) and passing quality audits with flying colors. In force since 2011, it was updated in April with a new focus on risk management.

FALLS CHURCH, Va., Oct. 11, 2018 /PRNewswire-PRWeb/ -- Understanding ISO 19011:2018 The Path to Better Medical Device

System Audits **An FDAnews Webinar** Oct. 30, 20181:30 p.m.3:00 p.m. ET http://www.fdanews.com/iso190112018

ISO 19011 is the rulebook for creating a device quality management system (QMS) and passing quality audits with flying colors. In force since 2011, it was updated in April with a new focus on risk management.

Chances are many devicemakers haven't implemented it yet. They may be wading through the minutiae right now, wishing for a coach to make the process go faster, easier.

Mark the calendar for a timely webinar featuring Dan O'Leary, FDAnews's go-to expert for quality management. Over the course of 90 minutes, he'll touch on the essentials of ISO 19011:2018 including establishment, implementation, monitoring, evaluation and competence of auditors, and the audit process itself. Prepare to discover:

  • The basics: Learning and applying the seven principles of auditing
  • The updates: How ISO 19011:2018 differs from ISO 19011:2011
  • The six major steps: Understanding the six major steps to conducting an audit
  • And how they apply: Establishing, implementing, monitoring, review and approval of an audit program
  • Auditor competence: Understanding and evaluating
  • Types of audit sampling: And when to apply them
  • Audit findings: Determining and recording
  • And much more

Bonus Material: Participants receive an audit program checklist, based on the new standard, to help ensure an efficient and effective implementation.

Auditing cuts across corporate lines. Devicemakers need to adopt best practices and understand the risk-based approach of ISO 19011:2018. This webinar delivers the goods to manage audit programs that support the QMS while providing practical information to management.

Meet the Presenter: Dan O'Leary, our go-to presenter on quality management, is President of Ombu Enterprises LLC, a consultancy offering training and execution in Operational Excellence focused on analytic skills and a systems approach to operations management. Mr. O'Leary has more than 30 years experience in quality, operations and program management in regulated industries including medical devices, clinical labs, aviation and defense. He is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who Will Benefit: Auditing is a multi-disciplinary activity. Quality auditors may come from a variety of departments and have varied backgrounds. Job functions that would benefit from the presentation include but aren't limited to:

  • C-Suite execs
  • Quality managers
  • Department managers
  • Process owners
  • Audit managers
  • Lead auditors
  • Internal auditors
  • Supplier quality auditors

Webinar Details: Understanding ISO 19011:2018 The Path to Better Medical Device System Audits **An FDAnews Webinar** Oct. 30, 20181:30 p.m.3:00 p.m. ET http://www.fdanews.com/iso190112018    

Tuition: $287 per site

Easy Ways to Register: Online:     http://www.fdanews.com/iso190112018                         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.

 

SOURCE FDAnews



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