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

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

Published: April, 2022

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  • Course Description
  • Course Qualification
  • Presenter
  • FAQ

Course Description

Overview

  • FDA compliance
    5 mins
  • Audit preparation
    13 mins
  • Audit Execution
    50 mins
  • Maintaining a system in a validated state
    61 mins
  • Disaster recovery planning
    82 mins

Course Description

Computerized systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product, or a raw material or packaging component used in conjunction with the product during the manufacturing, testing, or tracking processes).  Such a system must be validated by FDA guidelines for computerized systems and documented accordingly.

It is important to be able to identify computer systems used when performing FDA-regulated activities.  When a vendor is involved, whether in terms of provisioning hardware and/or software, implementing the system, or maintaining it, this must be done in compliance with FDA requirements.  A solid computer system validation strategy, along with an understanding of industry best practices, will lead your company to ensure that vendors are held accountable for the delivery of systems and services that will support your efforts to validate computer systems and maintain them in a validated state.

This CPE webinar will also guide you on the importance of factoring risk into all FDA-regulated activities and will help you assess the risk of any computer products purchased from third-party vendors. 

Major topics covered in this Online CPE Webinar course on Information Technology:

  • A strategic approach to vendor audit
  • Key areas of vendor performance that are necessary to ensure they will meet your compliance requirements
  • How to investigate 21 CFR Part 11 (electronic records/electronic signatures) compliance
  • Procedural controls are needed to support areas where there may be technical control gaps or weaknesses
  • Ways to leverage your vendor’s experience and expertise to assist with Installation Qualification and Operational Qualification
  • How to carefully document all activities related to your vendor to ensure compliance
  • Best industry audit practices to ensure FDA compliance

Learning Objectives

  • To explain how to identify “GxP” Systems
  • To discuss the Computer System Validation (CSV) approach based on FDA requirements
  • To discuss the System Development Life Cycle (SDLC) approach to validation
  • To describe the importance of performing a thorough vendor audit to ensure oversight of the products and services they deliver
  • To discuss the key characteristics to review when performing an onsite vendor audit
  • To explain how to use a Vendor Questionnaire as part of a vendor audit
  • To discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures
  • To describe how to maintain a system in a validated state through the system’s entire life cycle
  • To discuss how to assure the integrity of data that supports GxP work
  • To discuss 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 discuss the key components of 21 CFR Part 11 compliance for electronic records and signatures
  • To discuss the regulatory influences that lead to FDA’s current thinking at any given time

Recommended For

  • This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the Information Technology Professionals as this CPE course will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems.

Who Should Attend?

  • Accounting and audit managers/practitioners
  • Auditors
  • Certified Information Technology Professionals
  • Certified Public Accountant (CPA)
  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • Information Reporting Officers
  • IT Managers
  • Security personnel
  • Young CPA

Course Qualification

Webinar Qualifies For

  • 1.5 General Credit for Accountant/Bookeeper
  • 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 of System and Organization Controls Reporting for Certified Information Technology Professionals (CITP)
  • 1.5 CPE Credit of Information Technology for Certified Internal Auditors (CIA)
  • 1.5 CPE Credit of Information systems 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 CPA - Ireland
  • 1.5 CPD Credit for Chartered Accountants - Scotland

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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