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Developing a Strategic Approach to FDA Compliance for Computer Systems

  • 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
  • Course Description
  • Course Qualification
  • Presenter
  • FAQ

Course Description

Course Description

Effective and compliant computer system validation is critical to any FDA-regulated organization.  During the past 30 years, best practices have been developed and, if followed, can ensure laboratory computer systems are validated efficiently and in compliance with FDA regulations.  This CPE webinar will provide guidance for planning, executing, and validating a laboratory computer system, and managing the system in a validated state through the end of the system life cycle.

The CPE course will address roles and responsibilities, the timing of phases and deliverables, business process reengineering, organizational change management, change control, audit trails, training, and documentation.  You will learn what is required not only to validate your laboratory system but maintain it in a validated state until it is retired or otherwise no longer in use.

There is an enormous body of documentation and information available on computer system validation, which can be overwhelming.  This continuing education course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective methods, techniques, and tools available.

Major areas covered in this online CPE course:

  • System Development Life Cycle (SDLC) Methodology
  • Computer System Validation (CSV)
  • Good “Variable” Practice (GxP)
  • Good Manufacturing Practice (GMP)
  • Good Laboratory Practice (GLP)
  • GAMP 5 Guidance for System Classification
  • Risk Assessment and Management
  • Validation Strategy
  • Change Control and Audit Trails
  • User Requirements Specification (URS) & Functional Requirements Specification (FRS)
  • System Design Specification (SDS) and System Configuration Specification (SCS)
  • Test Planning, Execution, and Documentation (IQ/OQ/PQ)
  • Requirements Traceability Matrix (RTM)
  • System Acceptance, Release Notification, and Deployment
  • System Retirement
  • Data Governance Archival

Click here for more Information on technology webinars

Learning Objectives

  • To describe 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 determine how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11 
  • To comprehend the risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches 
  • To discuss appropriate validation strategies for many types of applications, including Cloud/SaaS, COTS, spreadsheets, and custom-developed systems 
  • To become aware of best practices and inspector expectations for computer system validation and software quality assurance (SQA) programs
  • To discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures
  • To determine how to maintain a system in a validated state through the system’s entire life cycle
  • To describe 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 regulatory influences that lead to FDA’s current thinking at any given time
  • To discuss how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
  • To explain the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP 5 category, and risk, should it fail, develop a cohesive and comprehensive validation rationale
  • To determine how to best prepare for an FDA inspection or audit of a GxP computer system
  • To describe the importance of performing a thorough vendor audit to ensure oversight of the products and services they deliver
  • 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 Information Technology Professionals who are responsible for planning, executing, or managing the implementation of any computer system governed by FDA regulations, or if are developing, configuring, maintaining, or supporting such a system.  

Who Should Attend?

  • Auditors
  • Certified Fraud Examiner
  • Certified Information Technology Professionals
  • Certified Management Accountant (CMA)
  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • IT Managers
  • Security personnel
  • Young CPA

Course Qualification

Webinar Qualifies For

  • 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 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 CPE Credit for Information Technology Certified Associate (ITCA)
  • 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/Bookeeper
  • 1.5 CPD Credit for Chartered Professional Accountant (CPA Canada)
  • 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 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

  • To receive Continuing Education credit for the event, you must register for the webcast prior to the start of each program.
  • Continuing Education Credit Certificate is available to all eligible participants within 24 hours of each webinar.
  • You must attend complete live webinar and respond to all polling questions asked during the webinar. Credits would be issued on 50 minute credit hour basis.
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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.
  • If you still face the polling problem please don’t panic and provide your response in the chat and we shall consider the same for processing for credits. You can download Zoom by clicking on the mentioned link : https://zoom.us/download
  • Our courses meet the global Continuing Professional Development (CPD-IES7) Standard for Chartered Accountants with International Education Standard 7 (IES 7) set by The International Federation of Accountants (IFAC), the International Accounting Education Standards Board (IAESB) and the Association of Chartered Certified Accountants (ACCA). Based on our accreditation by existing IFAC members and affiliates, we believe learners can count their professionally relevant, verifiable learning activities on myCPE, including taking on demand courses and attending live webinars, toward fulfillment of their verifiable CPD-IES7 requirements. However, if there is any question, we recommend that the individual learner confirm with his/her professional licensing organization before taking myCPE courses for CPD-IES7 credit.
  • You can manage your continuing education certificates and credits through your certificate dashboard which is available when you are logged in to your account (LOGIN)
  • As an accredited provider of Continuing Professional Education in the United States, myCPE online learning platform, courses, and webinars meet the requirements set forth by the Institute of Management Accountants (IMA), an IFAC Member Organization, as well as the National State Boards of Accountancy (NASBA) and the Institute of Internal Auditors (IIA), both IFAC Affiliates. As well as it has been approved by NASBA, Internal Revenue Service (IRS), Certified Financial Planner Board (CFP Board), California Tax Education Council (CTEC), Society of Human Resource Professional (SHRM), Human Resource Certification Institute (HRCI) and many more.Therefore, we believe learners can count their professionally relevant, verifiable learning activities on myCPE, including taking on demand courses and attending live webinars, toward fulfillment of their verifiable continuing education requirement as CPD-IES7 requirements. However, if there is any question, we recommend that the individual learner confirm with his/her professional licensing organization before taking myCPE courses for CPD-IES7 credit.
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Developing a Strategic Approach to FDA Compliance for Computer Systems

$15

1.5 Credits

Subject Area

Information Technology

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