21 CFR Part 11 (Electronic Records/Electronic Signatures)and FDA-Regulated Computer Systems

Duration: 60 Minutes
This webinar will help you understand in detail the application of FDA's 21 CFR Part 11 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.
Electronic Records/Electronic Signatures (ER/ES)
Instructor: Carolyn Troiano
Product ID: 500998

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.

Areas Covered
  • Gain an understanding of FDA's 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) guidance document
  • Develop the ability to apply 21 CFR Part 11 when implementing, validating and maintaining computer systems 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

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 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 adhere to 21 CFR Part 11 when planning, executing and maintaining computer system validation, and develop a sound strategy for meeting FDA compliance
  • The attendees will understand the level of effort required for executing each phase of the System Development Life Cycle methodology, as it pertains to ER/ES capability, and the appropriate level of documentation that must be completed to support it. They will also gain an understanding of the training and skills required to apply 21 CFR Part 11 to systems when validating or maintaining them
  • The attendees will have a good grasp of how to 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 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. This webinar will also benefit any consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

$375
Recorded Session for one participant
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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Instructor Profile:
Carolyn Troiano has more than 35 years of experience in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.
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