myCPE New Year Offer. Unlimited Continuing Education only @$299 $199 (Last Day) CLICK HERE to view.

Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning the Agile Methodology to the GAMP 5 “V” Model and System Development Life Cycle (SDLC) Methodology

  • CISA
  • CPA/CITP
  • CPA (US)
  • CISM
  • CRISC
  • CDPSE
  • ITCA
  • Course Description
  • Course Qualification
  • Presenter
  • Faq

Course Description

Course 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 create 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 the 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.

In this Information Technology CPE webinar, speaker Carolyn Troiano will help you to align the agile methodology to the GAMP5 “V” model and system development life cycle (SDLC) methodology.

Learning Objectives

  • To discuss how to identify “GxP” systems.
  • To inspect FDA’s current thinking about technology and software development, and how this will impact the industry.
  • To discuss the current state of the Computer System Validation (CSV) approach based on FDA requirements.
  • To analyze 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.
  • To explain the pros and cons of an Agile vs. Waterfall approach.
  • To analyze cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively.
  • To 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.
  • To analyze 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.
  • To investigate how to assure the integrity of data that supports GxP work, despite changes and advances in new technology.
  • To inspect the importance of “GxP” documentation that complies with FDA requirements.
  • To discuss the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state.
  • To analyze the regulatory influences that lead to FDA’s current thinking at any given time
  • To discuss 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.

Recommended For

  • This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the titles of ISACA who are responsible for planning, execution, and support of computer system validation activities. 

Who Should Attend?

  • Certified Information Technology Professionals
  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • Young CPA

Course Qualification

Webinar Qualifies For

  • 1.5 CPE Credit for Certified Data Privacy Solutions Engineer (CDPSE)
  • 1.5 CPE Credit for Certified in Risk and Information System Control (CRISC)
  • 1.5 CPE Credit for Certified Information Security Manager (CISM)
  • 1.5 CPE Credit for Certified Information Systems Auditor (CISA)
  • 1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
  • 1.5 CPE Credit for Information Technology Certified Associate (ITCA)
  • 1.5 CPD Credit of Information Technology for Certified Information Technology Professionals (CITP)

Presenter

About Presenter

Carolyn Troiano

Consultant BrainStorm Central Consulting LLC

Carolyn Troiano has more than 35 years of experience in computer system validation and compliance in the pharmaceutical, medical device, 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.

Faq

FAQs content

  • To receive Continuing Education credit for the event, you must register for the webcast prior to the start of each program.
  • Continuing Education Credit Certificate is available to all eligible participants within 24 hours of each webinar.
  • You must attend complete live webinar and respond to all polling questions asked during the webinar. Credits would be issued on 50 minute credit hour basis.
  • Polling feature Not supported: If you are logging in through browser or web portal in the browser (zoom.us) it doesn’t support the polling feature. Please be advised the current polling feature can only be supported via Zoom desktop and mobile app. You can check the same here : https://support.zoom.us/hc/en-us/articles/203749865-Polling-for-webinars
  • This event may be a recorded rebroadcast of a live event done in past and the instructor will be available to answer your questions during/after the webinar.
  • If you still face the polling problem please don’t panic and provide your response in the chat and we shall consider the same for processing for credits. You can download Zoom by clicking on the mentioned link : https://zoom.us/download
  • Our courses meet the global Continuing Professional Development (CPD-IES7) Standard for Chartered Accountants with International Education Standard 7 (IES 7) set by The International Federation of Accountants (IFAC), the International Accounting Education Standards Board (IAESB) and the Association of Chartered Certified Accountants (ACCA). Based on our accreditation by existing IFAC members and affiliates, we believe learners can count their professionally relevant, verifiable learning activities on myCPE, including taking on demand courses and attending live webinars, toward fulfillment of their verifiable CPD-IES7 requirements. However, if there is any question, we recommend that the individual learner confirm with his/her professional licensing organization before taking myCPE courses for CPD-IES7 credit.
  • You can manage your continuing education certificates and credits through your certificate dashboard which is available when you are logged in to your account (LOGIN)
  • As an accredited provider of Continuing Professional Education in the United States, myCPE online learning platform, courses, and webinars meet the requirements set forth by the Institute of Management Accountants (IMA), an IFAC Member Organization, as well as the National State Boards of Accountancy (NASBA) and the Institute of Internal Auditors (IIA), both IFAC Affiliates. As well as it has been approved by NASBA, Internal Revenue Service (IRS), Certified Financial Planner Board (CFP Board), California Tax Education Council (CTEC), Society of Human Resource Professional (SHRM), Human Resource Certification Institute (HRCI) and many more.Therefore, we believe learners can count their professionally relevant, verifiable learning activities on myCPE, including taking on demand courses and attending live webinars, toward fulfillment of their verifiable continuing education requirement as CPD-IES7 requirements. However, if there is any question, we recommend that the individual learner confirm with his/her professional licensing organization before taking myCPE courses for CPD-IES7 credit.
  • myCPE Courses are taken by : CPA | CMA | CFE | CIA | CPA(Yellow Book)| CFP | CFA | CPA (Govt.) | EA | CRTP | MRTP | ORTP | ABV | CITP | CVA | PFS | CFF and others.
Computer System Validation (CSV) vs. Computer System Assurance (CSA):  Aligning the Agile Methodology to the GAMP 5 “V” Model and System Development Life Cycle (SDLC) Methodology

$15

1.5 Credits

Subject Area

Information Technology

Upcoming Webinars

QBO Complete Comprehensive Overview - Latest
  • 4.3
  • (35)

Jan 18, 2022 | 09:00 AM EST

IFRS Fair Value Measurement
  • 4.4
  • (7)

Jan 18, 2022 | 09:30 AM EST

The Next 401(k) Scandal
  • 4.4
  • (109)

Jan 18, 2022 | 10:00 AM EST

Understanding Credit Card Frauds
  • 4.5
  • (8)

Jan 18, 2022 | 10:00 AM EST

Accounting & Auditing in a COVID World
  • 4.5
  • (36)

Jan 18, 2022 | 10:00 AM EST

Introduction to the Estate Tax
  • 4.5
  • (15)

Jan 18, 2022 | 10:00 AM EST