In-Depth Testing of Computer Systems Regulated by FDA

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

Published: May, 2022

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Before starting this self study program, please go through the instructional document.

  • Course Description
  • Course Qualification
  • Presenter
  • FAQ

Course Description

Overview

  • Computer system validation (CSV)
    5 mins
  • CSV vs. Computer software assurance (CSA)
    22 mins
  • Waterfall vs. Agile methodology
    34 mins
  • Validation planning
    39 mins
  • IQ, OQ, PQ Purpose and contents
    60 mins
  • CSV test summary report
    76 mins

Course Description

This CPE Webinar will focus on testing as a key element of Computer System Validation (CSV). 

The level of testing must reflect both the potential risk associated with the failure of the system to function properly. It must also be based on the systems’ classification in accordance with GAMP 5 and on a thorough risk assessment of what could happen if the system were to fail. A standard risk approach will be explained to incorporate into the testing to be done.

With the help of this CPE Information technology course, you will learn the way to develop a detailed rationale for testing and how to ensure that it is fully executed and documented in accordance with FDA requirements.

You will also be provided with guidance for maintaining the system in a validated state and assessing the level of any testing that might be required post-validation to ensure that compliance.

We will address all three phases of CSV testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Each phase has specific requirements and the approach taken is critical in terms of the resources and time required.

In this Online CPE Webinar course speaker, Carolyn Troiano will discuss ways to minimize costs while assuring maximum compliance with FDA requirements for CSV.

Learning Objectives

  • To determine the category of your system, based on GAMP 5 from ISPE.
  • To determine the risks associated with the various ways your system may fail.
  • To discuss the size, complexity, business criticality, category, and risk, and develop a rationale for the level of testing that will be needed to assure your system is thoroughly vetted.
  • To analyze the FDA requirements for documentation of all testing activities.
  • To inspect how to write a test protocol for each phase of testing: (1) Installation Qualification (IQ) (2) Operational Qualification (OQ) (3) Performance Qualification (PQ)
  • To investigate how to develop test scripts and acceptance criteria.
  • To analyze how to identify test discrepancies and distinguish the type:  test script errors, tester errors, system errors.
  • To inspect how to document all testing and the summary reports.
  • To investigate maintaining the system in a validated state, and keeping testing as a ‘living’ exercise that runs through the system life cycle.

Recommended For

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

Who Should Attend?

  • Assistant Controllers
  • CEO
  • Certified Fraud Examiner
  • Certified Information Technology Professionals
  • Certified Management Accountant (CMA)
  • Compliance Managers
  • Compliance Officers
  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • Information Reporting Officers
  • 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 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 CPD Credit for Certified Information Technology Professionals (CITP)
  • 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 of Information Technology for Certified Public Accountants (CPA-US)
  • 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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