Virtual Computer System Validation (CSV) Training Course: Advancements In Technology That Have Forced Organizations To Rethink Business Models (ON-DEMAND)
Virtual Computer System Validation (CSV) Training Course: Advancements In Technology That Have Forced Organizations To Rethink Business Models (ON-DEMAND) . (MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Computer System Validation Training Course" training has been added to  ResearchAndMarkets.com's  offering. ...
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(MENAFN- GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Computer System Validation Training Course" training has been added to ResearchAndMarkets.com's offering.

Advancements in have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges.

The approach to developing software, performing validation and maintaining a system in a validated state through its entire life cycle should be carefully considered in order to meet changing needs. This webinar will include a comparison of the agile and waterfall methodologies, along with the pros and cons of each. There may not be one size that fits all, and so it is important to understand what needs to be considered when making such a determination.

We'll also cover COTS, SaaS, IaaS, PaaS, and cloud services, indicating the benefits and risks of each model. In discussing these hardware and software options, we'll include the best practices for meeting FDA's requirements for validation, 21 CFR Part 11, as applicable, and data integrity. Part of the session will identify the FDA's current concerns and how to ensure your systems will meet their expectations.

Why should you attend

The attendee will learn about how to take advantage of modern, evolving technology while remaining compliant with FDA regulations related to computer systems and data. We will discuss ways to modernize the System Development Life Cycle (SDLC) approach to validation by applying FDA's draft guidance for Computer Software Assurance (CSA) using an agile approach, including automated testing tools that will result in a continuous validation of software products. The CSA approach is risk-based and relies heavily on critical thinking. It is aligned with GAMP5, Second Edition, published in July 2022. We will discuss the pros and cons of various approaches, and industry best practices for success.

The attendee will learn how to validate systems to meet 21 CFR Part 11, and data integrity compliance. We will touch on compliance with data privacy laws, including HIPAA, GDPRs, and other privacy regulations.

We will cover Computer-Off-the-Shelf (COTS) software, Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), Platform-as-a-Service (PaaS), and cloud services. You'll learn how to select an optimal solution and ensure that whatever that might be, you can build a contract and Service Level Agreement (SLA) that best suits your environment and needs.

We will also address spreadsheet validation. While tools like MS Excel, Google Sheets, and others do not have to be validated if used out-of-the-box without any customization. However, if you include macros or any type of customization, it will need to be validated. Learn about a streamlined approach to get a handle on the plethora of spreadsheets that are used across your organization for FDA-regulated data.

This seminar will be in-person, providing ample time for greater audience interaction. Bring your most pressing questions, describe you "pain points," and learn how to solve some of the most confounding issues related to validation.

Areas Covered



Learn how to identify "GxP" Systems

Learn about FDA's current thinking about technology and software development, and how this will impact industry

Discuss the current state of Computer System Validation (CSV) approach based on FDA requirements

Learn about the System Development Life Cycle (SDLC) approach to validation and how this can be modernized through a more agile approach, including automated testing for continuous validation

Learn about cloud services and cloud service providers to optimize your experience

Learn ways to validate in the cloud without compromising quality or compliance

Learn the pros and cons of an agile vs. waterfall approach

We will discuss cloud computing and Software-as-a-Service (SaaS), Infrastructure-as-a-Service (IaaS), and Platform-as-a-Service (PaaS) systems that can be embraced and validated effectively

Discuss the best practices for documenting computer system validation efforts, whether using a waterfall or agile approach, including requirements, design, development, testing and operational maintenance procedures, including ways to improve efficiency and effectiveness of managing related documentation

Understand the best approach to Installation Qualification (IQ) testing when the system components are not on premise, but are in the cloud

Understand how to maintain a system in a validated state through the system's entire life cycle in a more cost-effective manner, applying an agile continuous validation approach

Learn how to assure the integrity of data that supports GxP work, despite changes and advances in new technology

Discuss the importance of "GxP" documentation that complies with FDA requirements

Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state

Know the regulatory influences that lead to FDA's current thinking at any given time

Learn about current trends in FDA compliance and enforcement

Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle Q&A

RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Who Should Attend:



Information Technology Analysts

Information Technology Developers and Testers

Software Quality Assurance Professionals

QC/QA Managers and Analysts

Analytical Chemists

Compliance and Audit Managers

Laboratory Managers

Automation Analysts

Manufacturing Specialists and Managers

Supply Chain Specialists and Managers

Regulatory Affairs Specialists

Regulatory Submissions Specialists

Risk Management Professionals

Clinical Data Analysts

Clinical Data Managers

Clinical Trial Sponsors

Computer System Validation Specialists

GMP Training Specialists

Business Stakeholders/Subject Matter Experts

Business System/Application Testers

Vendors responsible for software development, testing and maintenance Vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Speakers:

Carolyn Troiano

Webinar/Seminar/Workshop Instructor in FDA Compliance Training

Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device 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

For more information about this training visit

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https://menafn.com/1108865040/Virtual-Computer-System-Validation-CSV-Training-Course-Advancements-In-Technology-That-Have-Forced-Organizations-To-Rethink-Business-Models-ON-DEMAND
2024-11-08
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(MENAFN - GlobeNewsWire - Nasdaq) Dublin, Nov. 08, 2024 (GLOBE NEWSWIRE) -- The "Computer System Validation Training Course" training has been added to  ResearchAndMarkets.com's  offering. ...
Virtual Computer System Validation (CSV) Training Course: Advancements In Technology That Have Forced Organizations To Rethink Business Models (ON-DEMAND)