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 3. 3-HOUR VIRTUAL SEMINAR ON COMPUTER SYSTEM VALIDATION (CSV) VS COMPUTER
    SOFTWARE ASSURANCE (CSA) - FOLLOWING A WATERFALL VS AGILE METHODOLOGY


3-HOUR VIRTUAL SEMINAR ON COMPUTER SYSTEM VALIDATION (CSV) VS COMPUTER SOFTWARE
ASSURANCE (CSA) - FOLLOWING A WATERFALL VS AGILE METHODOLOGY

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FACULTY: CAROLYN TROIANO

Scheduled Date : March 08 2022

Scheduled Time : 12pm -  3pm ET



DESCRIPTION:

As part of the Case for Quality program US FDA Center for Devices and
Radiological Health noted how an excessive focus by industry on compliance
rather than quality may be diverting resources and management attention toward
meeting regulatory compliance requirements vs. adopting best quality practices.
There has also been a lower than anticipated investment in automation and
digital technologies, which could greatly improve quality and process control. A
key element is a risk-based, product quality and patient-centric approach to
Computer System Assurance (CSA) vs. the traditional Computer System Validation
(CSV) Waterfall approach. This encourages critical thinking based on product and
process knowledge and quality risk management over prescriptive documentation
driven approaches. 

This is where FDA determined that “WHAT” is required can be done (the “HOW”) in
different ways and does not have to be according to the “checklist” mindset of
most CSV work, where you crank out documents without specifically addressing the
risk of potential failure of each requirement. 

GAMP5 supports the use of incremental, iterative, and evolutionary approaches
including Agile, for development of custom applications. Keys to success include
a robust Quality Management System and well trained and highly disciplined teams
following well-defined processes supported by tools and automation

Advancements in technology 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.

Why Should You Attend:

The attendee will learn about FDA’s approach to modernizing technology, and how
that will benefit both the Agency and industry. We will discuss ways to
modernize the System Development Life Cycle (SDLC) approach to Computer System
Validation (CSV) by using automated testing tools that will result in a
continuous validation of software products. This approach is amenable to the
Agile software development methodology, which can be adapted for use in
validation.

We will also discuss the important aspects of CSV and how to apply them in a new
and modern technological environment.

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
 * 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

Seminar Agenda:

 * 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 the pros and cons of an Agile vs. Waterfall approach
 * We will discuss cloud computing and Software as a Service (SaaS) 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 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
 * 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



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FDA CSV CSV vs CSA Carolyn Trooiano
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SUPPLIER AND CONTRACT MANUFACTURER MANAGEMENT
COMPUTER SYSTEM VALIDATION (CSV) BOOT CAMP
AUDIT LIKE THE FDA - EFFECTIVE INTERNAL AUDIT PROGRAM

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