Environmental Controls for Devicemakers - Webinar CD/Transcript
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
You’ll receive a checklist based on the regulation, warning letters and QSIT to help ensure compliance.