Environmental Controls for Devicemakers - Webinar CD/Transcript

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Environmental Controls for Devicemakers

Environmental controls are a significant issue for medical device manufacturers.

To help you effectively implement environmental controls you must understand their underlying issues. This presentation 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 you an opportunity to learn from the mistakes of others.

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

In 90 minutes you will learn:

  • Environmental conditions that could affect product quality
  • The content of procedures to address the environmental conditions
  • How to identify your 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
  • About the 2015 standards on cleanrooms

Bonus Material
You’ll receive a checklist based on the regulation, warning letters and QSIT to help ensure compliance.

  • 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

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.