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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

  • Accountant
  • CPA (CA)
  • CFE
  • CGFM
  • CISA
  • CPA/CITP
  • CIA
  • CMA
  • CPA (US)
  • CA - ICAEW
  • ACCA
  • FPAC
  • CA - Ireland
  • CA - Scotland
  • CPA - Ireland
  • CFIRS
  • CWS
  • 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.

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

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?

  • Assistant Controllers
  • Business Owner
  • CEO
  • Certified Information Technology Professionals
  • CFO/Controller
  • Compliance Managers
  • Compliance Officers
  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • CPA in Business
  • Entrepreneurial CPA
  • Information Reporting Officers
  • Young CPA

Course Qualification

Webinar Qualifies For

  • 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 CPD Credit for Certified Information Technology Professionals (CITP)
  • 1.5 CPD Credit for Chartered Professional Accountant (CPA Canada)
  • 1.5 CPE Credit for Certified Fraud Examiner (CFE)
  • 1.5 CPE Credit for Certified Government Financial Manager (CGFM)
  • 1.5 CPE Credit for Certified Internal Auditors (CIA)
  • 1.5 CPE Credit for Certified Management Accountants (CMA)
  • 1.5 CRE Credit for Certified Corporate FP&A Professional (FPAC)
  • 1.5 CE Credit for Certified Fiduciary & Investment Risk Specialist (CFIRS)
  • 1.5 CE Credit for Certified Wealth Strategist (CWS)
  • 1.5 General Credit for Accountant/Bookkeeper/Tax Professionals
  • 1.5 CPD Credit for CA - ICAEW
  • 1.5 CPD Credit for Chartered Certified Accountants (ACCA)
  • 1.5 CPD Credit for Chartered Accountants - Ireland (CAI)
  • 1.5 CPD Credit for Chartered Accountants - Scotland
  • 1.5 CPD Credit for CPA - Ireland

Additional details

  • Course Level :
    Basic
  • Credits :
    1.5
  • Instructional Method :
    Group Internet Based
  • Pre-requisites :
    None
  • Advance Preparation :
    None

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.

Presenter

About Presenter

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.

About Company

BrainStorm Central Consulting LLC

BrainStorm Central Consulting is the leader and premier catalyst for moving companies to a new level by outstripping conventional wisdom and thought, and creating a strategy that goes beyond the realm of “better, faster, cheaper”.


"Our experience will lead you to us, your experience will keep you coming back..."


FDA Compliance Training Topics Offered:

• Developing a Strategic Approach to FDA Compliance for Computer Systems

• FDA’s Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

• Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

• Medical Device Industry Trends for Computer Systems Regulated by FDA

• Tobacco and Related Industry Trends for Computer Systems Regulated by FDA

• FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars

• FDA Compliance and Mobile Applications

• Good Documentation Practices to Support FDA Computer System Validation

• In-Depth Computer System Testing of Computer Systems Regulated by FDA

• Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA

• Data Integrity and Governance for Computer Systems Regulated by FDA

• Trends in FDA Compliance and Enforcement for Regulated Systems

• Best Practices in Preparation for an FDA Computer System Audit

• Functional System Requirements for Computer Systems Regulated by FDA

• Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

• 21 CFR Part 11 (e-Records/Signatures) Compliance for Computer Systems Regulated by FDA

• C-TPAT Compliance for FDA-Regulated Industries

• Medical Device Cybersecurity and FDA Compliance

• 21st Century Cures Act and Medical Device Software Compliance

• Medical Device Software 62304 Compliance

• Creating, Reviewing & Managing Audit Trails: Compliance for FDA-Regulated Computer Systems

• Best Practices for Responding to a Form 483 Citation and/or Warning Letter Issued by FDA

Faq

FAQs content

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  • 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.
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Ratings and Review

4.3

64 Ratings

Excellent

29

Very Good

26

Average

9

Poor

0

Terrible

0

DB

David Brady, CPA (US)

Apr 7th, 2022

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

TV

Thinh Vuong, CPA (US)

Feb 22nd, 2022

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

MEM

Mary Ellen Morris, CPA (US)

Apr 7th, 2022

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

NS

Nick Shields, CPA (US)

Feb 22nd, 2022

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

Ahmed Sameer Khan
Ahmed Sameer Khan, ACCA

Feb 22nd, 2022

Well, thank you so much!

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

PREMIUM

1.5 Credits

Subject Area

Information Technology

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