FDAnews Announces — Medical Device Process Validation Webinar, Sept. 29, 2016

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When must a process be validated? Join industry expert Dan O’Leary, president of Ombu Enterprises, LLC, on Sept. 29 as he discusses the fundamental requirements of medical device process validation and uses warning letters to illustrate best practices.

FDAnews

FDAnews

Medical Device Process Validation
**An FDAnews Webinar**
Sept. 29, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://info.fdanews.com/medical-device-process-validation-pr

When must a process be validated?

That’s the first crucial question devicemakers must answer. But with no clear guidance from the FDA, finding the answer can be difficult.

And, approximately one-third of all warning letters related to QSR cite process validation as the problem. What can you do to remain compliant?

Join industry expert Dan O’Leary, president of Ombu Enterprises, LLC, as he discusses the fundamental requirements of medical device process validation and uses warning letters to illustrate best practices.

After attending this 90-minute webinar you will:

  • Understand the three phases of process validation in QSR
  • Understand the role of IQ, OQ, and PQ in the first phase
  • Learn the issues of parameter control, data collection, and data analysis applied to production runs
  • Review the QSIT approach and how FDA Investigators apply it
  • Analyze warning letters and apply lessons learned
  • Realize the differences introduced in ISO 13485:2016

Bonus Materials: Attendees will receive a QSR checklist to help ensure compliant implementation and a comparative analysis of QSR and ISO 13485:2016 requirements.
Register today and discover how to set up a compliant process validation system.

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 experience in quality, operations, and program management in regulated industries including: aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; 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:

  • Design Engineers, especially engineers in design transfer
  • Manufacturing Engineers, especially engineers in design transfer
  • Quality Engineers
  • Quality Auditors
  • Regulatory Affairs
  • Quality Systems Personnel
  • R&D and Engineering Staff
  • Risk Managers
  • Production Supervisors

Webinar Details:
Medical Device Process Validation
Sept. 29, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://info.fdanews.com/medical-device-process-validation-pr

Tuition:
$287 per site

Easy Ways to Register:
Online: http://info.fdanews.com/medical-device-process-validation-pr                            
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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