In-Depth Functional and System Requirements for Computer Systems Regulated by FDA

  • Accountant
  • CPA (CA)
  • CFE
  • CGFM
  • CISA
  • CPA/CITP
  • CIA
  • CMA
  • CPA (US)
  • CA - ICAEW
  • ACCA
  • CISM
  • CRISC
  • CGEIT
  • CSX-P
  • CDPSE
  • ITCA
  • CET
  • FPAC
  • CA - Ireland
  • CA - Scotland
  • CPA - Ireland
  • CFIRS
  • CWS

Published: May, 2022

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  • Course Description
  • Course Qualification
  • Presenter
  • FAQ

Course Description

Overview

  • FDA regulatory oversight
    3 mins
  • Computer system validation (CSV)
    9 mins
  • Computer system risk assessment
    22 mins
  • Business process Re-engineering (BPR)
    56 mins
  • Waterfall vs. Agile methodology
    70 mins

Course Description

Computer System Validation (CSV) has been regulated by FDA for more than 35 years, as it relates to systems used in the manufacture, testing, distribution, and management of a product in the pharmaceutical, biotechnology, medical device, tobacco, and related industries. The requirements phase of the CSV process is a key aspect of validating a system by providing the functions and features the user will require to perform their operations.

This CPE course will focus on the key aspects of requirements development and management, including best practices and principles for handling this key component of project work in an FDA-regulated environment (i.e., the system “touches” product during the manufacturing, testing, or distribution of the product, or any other functional activity). 

The material will include the various aspects of how to develop requirements, and the result will be a prescriptive approach to helping teams and individuals reach a higher level of compliance. It will also guide how to keep costs low and avoid “scope creep,” which can lengthen the time and require more money to achieve.

Requirements include both functional and non-functional, or system requirements. We’ll describe the differences and elaborate on the key characteristics of a well-written requirement. The approach includes determining risk at the requirement level and providing a risk rating for each that can be used to determine the type and level of testing required.

Requirements at a high level should be documented using business terminology to describe the intended use of the system. The high-level requirements are then used as a basis for developing the unique functional requirements and non-functional, or system requirements. Requirements will be mapped to one or more test script(s) that will be executed to prove the requirement is met.

This CPE information technology webinar will help you to learn about the best practices for preparing detailed requirements during CSV, including the acceptance criteria that must be met to assure the requirement is proven through testing.

Learning Objectives

  • To discuss the characteristics of well-written requirements.
  • To analyze where to gather information and who to speak with when preparing a requirements specification.
  • To discuss the importance of clearly written, well-defined requirement definition.
  • To analyze how the requirements will set the tone for CSV testing.
  • To inspect the Requirements Traceability Matrix (RTM) that links every requirement with one or more test scripts that support it.
  • To investigate how to rate the potential risk of a requirement failing and how this influences testing during CSV.
  • To identify functional vs. non-functional, or system requirements.

Recommended For

  • This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all IT professionals who want to understand In-Depth Functionality and System Requirements for Computer Systems Regulated by FDA.

Who Should Attend?

  • Certified Fraud Examiner
  • Certified Information Technology Professionals
  • Certified Management Accountant (CMA)
  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • Cybersecurity Pros
  • Young CPA

Course Qualification

Webinar Qualifies For

  • 1.5 General Credit for Accountant/Bookeeper
  • 1.5 CPE Credit for Certified Information Systems Auditor (CISA)
  • 1.5 CPE Credit for Certified Information Security Manager (CISM)
  • 1.5 CPE Credit for Certified in Risk and Information System Control (CRISC)
  • 1.5 CPE Credit for Certified Data Privacy Solutions Engineer (CDPSE)
  • 1.5 CPD Credit for Certified Information Technology Professionals (CITP)
  • 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 Chartered Professional Accountant (CPA Canada)
  • 1.5 CPE Credit of Information Technology for Certified Fraud Examiner (CFE)
  • 1.5 CPE Credit for Certified Government Financial Manager (CGFM)
  • 1.5 CPE Credit of Information security for Certified Internal Auditors (CIA)
  • 1.5 CPE Credit of Computer Software and Applications for Certified Management Accountants (CMA)
  • 1.5 CPE Credit for Certified in the Governance of Enterprise IT (CGEIT)
  • 1.5 CPE Credit for CSX Cybersecurity Practitioner (CSX-P)
  • 1.5 CPE Credit for Certified In Emerging Technology (CET).
  • 1.5 CRE Credit of Information Technology (inc. Excel) 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 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 :
    QAS Self Study
  • 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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