Policies and Procedures Required to Support Validation of Computer Systems Regulated by FDA
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Instructor Profile
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution. During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why should 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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives
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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. ď ś 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. ď ś 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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit 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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
How this Webinar Works Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com