21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA - By AtoZ Compliance | February 17, 2016 1:00 PM - February 17, 2016 2:00 PM | Automation.com

21 CFR Part 11 (Electronic Records/Signatures) Compliance for Computer Systems Regulated by FDA - By AtoZ Compliance

Event Summary

February 17, 2016
New Hyde Park, NY 11040
United States
February 17, 2016 1:00 PM
February 17, 2016 2:00 PM
[email protected]
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This webinar will help you understand in detail the application of FDA’s 21 CFR Part 11 compliance guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

Why Should You Attend

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that uses ER/ES capability, or if you are maintaining or supporting such a system. Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance. There is an enormous body of documentation and information available that can be overwhelming. This webinar 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.

Areas Covered In This Webinar

Gain an understanding of FDA’s 21 CFR Part 11 guidance document for electronic medical records training
Develop the ability to apply 21 CFR Part 11 when implementing, and maintaining computer system validation in your organization
Understand the best practices for maintaining a computer system with ER/ES capability in a validated state
Discuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriately
Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, as it applies to the use of ER/ES capability
Understand how to effectively document the process of computer system validation where ER/ES capability exists, and maintain current information about the various systems in your organization and how they are maintained in a validated state
Learn how to gain information about trends in ER/ES validation, as industry progresses and new best practices emerge
Understand some of the key “pitfalls” to avoid when employing ER/ES capability

Learning Objectives

Get an understanding of how to adhere to 21 CFR Part 11 guidelines when planning, executing and maintaining computer system validation
Develop a sound strategy for meeting FDA compliance
Understand the level of effort required for executing each phase of the System Development Life Cycle methodology, as it pertains to ER/ES capability
The appropriate level of documentation that must be completed to support it
Gain an understanding of the training and skills required to apply 21 CFR Part 11 to systems when validating or maintaining them
Leverage these practices across all systems by creating a standardized program for applying 21 CFR Part 11 guidelines to systems in accordance with FDA requirements

Who Will 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

Speakers Profile

Carolyn Troiano

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the PMI, AITP, RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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