Risk Based Approach to Software Quality Validation | October 28, 2015 10:00 AM - October 28, 2015 1:00 PM | Automation.com

Risk Based Approach to Software Quality Validation

Event Summary

DATE:
October 28, 2015
START DATE/TIME:
October 28, 2015 10:00 AM
END DATE/TIME:
October 28, 2015 1:00 PM
TIME ZONE:
(GMT -8:00) Pacific Time (US & Canada)
EVENT TYPE:
Webinar
HOST:
OnlineCompliancePanel
PHONE:
+1-510-857-5896
EMAIL:
[email protected]
WEBSITE:
Click here to Visit

Description

Description

This webinar will discuss developing procedures for including risk management in software quality validation; risk management standard operating procedure development and maintenance; standard operating procedures for step-by-step activities; measure quality and demonstrate compliance to risk management requirements; and produce quality validation records.

During the last several years, the FDA has increased its emphasis on risk management. At the same time new technologies are changing the way many things are done in the Pharmaceutical, Medical Device, and other industries. This has increased the importance and use of risk management procedures for much of the work that is done today.

Areas Covered

The development of SOPs that include risk management
The risk management in regulatory compliance
The organization of Computer Validation processes that include risk management
How to prepare necessary SOPs
The content and format of SOPs
The responsibilities of the various stakeholders

Why Should you Attend

This course will put you in a position to better include risk in decisions regarding what activities are required to better demonstrate compliance.

Objectives of the Presentation

How to organize the risk management processes and procedures
How to develop SOPs that include risk management
The development of training modules to support the SOPs
The production of "risk products" that provide quality records and fit with Computer Validation
How to apply change control to risk management
Who are and what are the roles of the various Stakeholders?

Who can Benefit

Quality Assurance Staff
Auditors
Subject Managers
IT Staff
Regulatory Affairs

Note: Use Coupon code 1371 and get 10% off on registration.

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