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

Welcome to myCPE

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.

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.

Speaker Carolyn Troiano, intensely speaks on Computer System Validation and Compliance.

Webinar Qualifies For

1.5 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
1.5 General Credit for Accountant/Bookkeeper/Tax Professionals
1.5 CPD Credit for CPA in Canada
1.5 CPE Credit for Certified Internal Auditors (CIA)
1.5 CPE Credit for Certified Fraud Examiner (CFE)
1.5 CPE Credit for Certified Management Accountants (CMA)
1.5 CPE Credit for Certified Information Systems Auditor (CISA)
1.5 CPD Credit for Association of Chartered Certified Accountants (ACCA)
1.5 CPE Credit for Certified Government Financial Manager (CGFM)
1.5 CPD Credit for Certified Information Technology Professionals (CITP)
1.5 CPD Credit for Chartered Accountant - ICAEW
1.5 CE Credit for Certified Wealth Strategist (CWS)
1.5 CE Credit for Certified Fiduciary and Investment Risk Specialist (CFIRS)
1.5 CE Credit for Certified FP&A Professional (FP&A)
1.5 CPD Credit for Chartered Accountants - Scotland
1.5 CPD Credit for Chartered Accountants - Ireland (CAI)
1.5 CPD Credit for CPA - Ireland

About Instructor

Carolyn Troiano

Account Executive, 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.

Additional Information

Duration

1.5 Hours

Course Level

Basic

Instructional Method

Group Internet Based

Pre-requisites

None

Advance Preparation

None

FAQ’s

Click Here to View

NASBA APPROVED

MY-CPE LLC, 1600 Highway 6 south, suite 250, sugar land, TX, 77478

MY-CPE LLC (Sponsor Id#: 143597) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.NASBARegistry.org.

Ratings and Review

4.3

Excellent

Very Good

Average

Poor

Terrible

David Brady, CPA (US)

Instructor was obviously very knowledgeable. She covered a huge amount of ground of a very technical subject matter.

Thinh Vuong, CPA (US)

myCPE is great platform for CPE as has relevant topics and great experts running them.

MEM

Mary Ellen Morris, CPA (US)

This was an outstanding detail presentation I'm a very complicated topic

Nick Shields, CPA (US)

Great seminar with a speaker who was well versed in the topic

ASK

Ahmed Sameer Khan, ACCA

Well, thank you so much!

1.5 Credits

Add to Watchlist

Subject Area

Information Technology

Completed

This course is set to be rescheduled shortly. Please fill out the short form below, and we'll let you know as soon as the course becomes available

Didn’t received verification email? Resend Email

Live Webinars

On Demand Webinars

Virtual Conferences

Specialized Packages

Advanced Certification Programs

myCPE Shorts Trending

Preparer Course

U.S. Individual Tax Preparer Course

U.S. Business Tax Preparer Course

Exam Prep Course

EA Exam Prep Course

CFP® Review Course

Teams Subscription (Per User)

Individual Subscription

Contact Sales Team

646-688-2884

inquiry@my-cpe.com

Schedule a Call

Flat $300 Off

Flat $640 Off

Flat $1000 Off

6 Million+

100K+

"Steven was knowledgeable and thorough…”

Crystal lovejoy

"Great Customer Service”

Lori corry

"It is what it advertised to be”

Brian Carey

"Great customer service”

Steve

Get 60% Off

Get 64% Off

Get 67% Off

Verification Code

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

Course Details

Learning Objectives

Course Description

Qualifies for

Webinar Qualifies For

Presenter Details

About Instructor

Carolyn Troiano

Other Details

Additional Information

1.5 Hours

Basic

Group Internet Based

None

None

FAQ’s

NASBA APPROVED

Ratings and Review

4.3

David Brady, CPA (US)

Thinh Vuong, CPA (US)

Mary Ellen Morris, CPA (US)

Nick Shields, CPA (US)

Ahmed Sameer Khan, ACCA

Subject Area

Recommended Webinars

Supply Chain Risk - The Impact on Privacy and Security

Introduction to Power Query

From Numbers to Nodes: Navigating the IoT Landscape in Accounting

CFP^® Review Course