FDAnews Announces — Environmental Controls for Devicemakers Webinar, Feb. 25, 2016

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Environmental controls are a significant issue for medical device manufacturers. This webinar explains the regulation and uses the regulation’s preamble to help clarify the FDA’s intent.

Environmental Controls for Devicemakers
Feb. 25, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/environmentalcontrolsdv

Environmental controls are a significant issue for medical device manufacturers.

To effectively implement environmental controls devicemakers must understand the underlying issues. This webinar explains the regulation and uses the regulation’s preamble to help clarify the FDA’s intent. In addition, a warning letter analysis categorizes and describes inspection issues; giving attendees an opportunity to learn from the mistakes of others.

Join industry expert Dan O’Leary, President of Ombu Enterprises, LLC on Feb. 25th as he helps attendees understand environmental controls and shows how to effectively implement the requirements. Using examples from recent warning letters he analyzes the problems raised and presents solutions that can be implemented immediately.

In 90 minutes attendees will learn:

  • Environmental conditions that could affect product quality
  • The content of procedures to address the environmental conditions
  • How to identify environmental systems
  • Maintenance activities and record keeping requirements
  • Common problems and how to avoid them
  • Linkage to other requirements such as contamination control and buildings
  • Correction and corrective action related to environmental controls
  • Sampling plans for environmental control and monitoring

Bonus Material:
Attendees receive a checklist based on the regulation, warning letters and QSIT to help ensure compliance.

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:

  • Quality Assurance Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Affairs Managers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Maintenance Managers
  • Maintenance Supervisors
  • Complaint Unit Managers
  • Quality Data Analysts
  • Risk Managers
  • MDR Managers and Specialists

Webinar Details:
Environmental Controls for Devicemakers
Feb. 25, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/environmentalcontrolsdv

Tuition:
$287 per site

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