QUALITY SYSTEMS

QUALITY SYSTEMS COURSE OPTIONS

This one hour web based training course provides an overview of the Investigations and CAPA system and process. It highlights the key compliance drivers and regulatory requirements. Understand correction, corrective action, and prevention.  This module is also available in Spanish!

This course discusses a high-level understanding of technical writing and why it is important to your business and compliance drivers. Learners will discover key steps in planning and preparing documents. Technical writing applies to various types of documents; standard operating procedures, investigations documentation, validation documentation, and change documents.

This hour-long web based training (WBT) module is an introductory course designed to help your organization better understand Quality Risk Management. It covers key terms, and what the FDA requires in defining the Quality Risk Management process.

This hour long Web Based Training module is an introduction to Quality Change Control. It focuses key terms and definitions, regulatory requirements and best practice approaches to support the system. It provides the background for you employees and partners to understand the importance of the Quality Change Control System.

This hour-long Human Factors and Performance web based training discusses a basic understanding of Human Performance.This course is designed to introduce Human Factors and Performance into your organization. We provide an overview of the influences in human factors and performance to systems, organizations, and people.

This three-module web based training course teaches how to prepare for an inspection, what to expect during an inspection, how to manage and inspection and the roles and responsibilities during an inspection. The modules can be assigned independently to different personnel in your organization based on their involvement with inspections. Inspection Readiness training is appropriate for all employees at your site.  Specific modules are designed for those involved in the inspection process or on the inspection team.

Review the requirements for 21 CFR Part 11, Public Docket 92S-0251, open and closed systems and electronic signatures. Know the importance in using good documentation practices as we transition to a more paperless society.