Training Course Syllabus:

Policies and Procedures Required to Support Validation of Computer Systems Regulated by FDA Webinar

Time: 10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Carolyn Troiano

Description:

Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. This webinar will discuss in detail the categories and variety of policies and procedures required to support activities related to computer system validation for systems subject to FDA regulations.

The webinar will also cover areas including:

• How policies and procedures should be prepared to support validation work for systems subject to FDA regulations.


• The best practices for determining and applying policies and procedures to ensure computer systems subject to FDA are maintained in a validated state.


• How to develop the appropriate policies and procedures to ensure a good balance of cost vs. risk.


• How to effectively create and maintain policies and procedures to support computer system validation.


• How to gain information about trends in policies and procedures as industry progresses and new best practices emerge.


• Understand some of the key "pitfalls" to avoid when developing and implementing policies and procedures to support computer system validation.

Why Should you Attend:

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any computer system that is part of a system governed by FDA regulations, or if you are maintaining or supporting such a system. There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques and tools available.

Objectives of the Presentation:

Upon completion of this session, attendees will have an understanding of how to develop, implement and maintain the policies and procedures required to support computer system validation, and develop a sound strategy for meeting FDA compliance.

It will provide the participants with a good understanding of the level of effort required for planning and executing the development and implementation of policies and procedures, including any training required, and the appropriate level of documentation that must be completed to support it.

The live training session will provide a good grasp of how to leverage these practices across all systems by creating a standardized program to apply to policies and procedures that support computer system validation in accordance with FDA requirements.

Who Should Attend

Information technology analysts, QC/QA managers and analysts, clinical data managers and scientists, analytical chemists, compliance managers, lab managers, automation analysts, computer system validation specialists, GMP training specialists, business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit, or the development of the policies and procedures to support these activities. This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Seminar Summary:

Learn policies and procedures required to support activities related to computer system validation for systems subject to FDA regulations in this webinar. (see full course description)

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