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Module 4: Performance Evaluation and Improvement Elements
The final module in this course reviews and examines the ISO requirements for Performance Evaluation and Improvement. The module reviews the “big pi...
GCP Refresher - Reporting Requirements for Clinical Investigations of Devices
Explains the reporting requirements of 21 CFR 812 (the FDA regulations for the conduct of clinical investigations of devices) and International Organi...
Module 2 – Planning Elements
This module explores the planning elements from ISO 45001. It considers how to identify hazards and prioritize them according to risks. Further, it co...
Module 3 – Support and Operation Elements
This module discusses the elements that support and implement the occupational health and safety (OH&S) planning requirements developed in previou...
GCP Refresher - Reporting Requirements for Clinical Investigations of Devices
Explains the reporting requirements of 21 CFR 812 (the FDA regulations for the conduct of clinical investigations of devices) and International Organi...
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