Best Practices in Preparation for an FDA Computer System Audit

  • Accountant
  • CISA
  • CPA/CITP
  • CPA (US)
  • CRISC
  • CFIRS
  • CWS
  • Course Description
  • Course Qualification
  • Presenter
  • FAQ

Course Description

Course Description

As a “GxP” system, following Good Manufacturing, Laboratory, and Clinical Practices, the computer system must be validated following FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.

This CPE webinar will focus on the most important key areas, including security and data integrity.

Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

In preparation for an audit, it is important to assess the documentation that was prepared when each GxP system was validated to identify and remediate any gaps or issues. The FDA contact person(s) should be able to tell the story of how each system came into production in a validated state and how each system is maintained in that validated state with the data integrity assured.

It’s important to have the right resources and understanding of the process before any inspection.  Having the validation information available and key resources who can speak to various components of it is critical and should be arranged in advance.

With the help of this CPE webinar, you will learn some tips based on real FDA inspections.

Learning Objectives

  • To discuss the regulatory influences that lead to FDA’s current thinking at any given time.
  • To analyze how to best prepare for an FDA inspection or audit of a GxP computer system.
  • To analyze best practices and inspector expectations for computer system validation and software quality assurance (SQA) programs.
  • To explain the importance of performing a thorough vendor audit to ensure oversight of the products and services they deliver to be able to defend the decision to choose them.
  • To analyze 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.
  • To inspect how to identify “GxP” Systems.
  • To discuss the Computer System Validation (CSV) approach based on FDA requirements.
  • To investigate the System Development Life Cycle (SDLC) approach to validation.
  • To analyze 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 analyze 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 investigate the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state.

Recommended For

  • This CPE webinar is recommended for CPAs, CISA, CISM, CRISC, and all the titles of ISACA who want to understand Best Practices in Preparation for an FDA Computer System Audit.

Who Should Attend?

  • CEO
  • Certified Information Technology Professionals
  • Compliance Managers
  • Compliance Officers
  • CPA (Industry)
  • CPA - Mid Size Firm
  • CPA - Small Firm
  • CPA in Business
  • 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 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 CPE Credit for Certified in Risk and Information System Control (CRISC)

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.
  • Polling feature Not supported: If you are logging in through browser or web portal in the browser (zoom.us) it doesn’t support the polling feature. Please be advised the current polling feature can only be supported via Zoom desktop and mobile app. You can check the same here : https://support.zoom.us/hc/en-us/articles/203749865-Polling-for-webinars
  • 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.
  • myCPE Courses are taken by : CPA | CMA | CFE | CIA | CPA(Yellow Book)| CFP | CFA | CPA (Govt.) | EA | CRTP | MRTP | ORTP | ABV | CITP | CVA | PFS | CFF and others.
Best Practices in Preparation for an FDA Computer System Audit

PREMIUM

1.5 Credits

Subject Area

Information Technology

Upcoming Webinars

Common Frauds in Governmental Entities
  • 4.6
  • (30)

Aug 22, 2022 | 10:00 AM EDT

The Structure and Organization of the IRS
  • 4.6
  • (1227)

Aug 22, 2022 | 10:00 AM EDT

How to Prepare Financial Statements
  • 4.2
  • (29)

Aug 22, 2022 | 10:00 AM EDT

From Mind-full to Mindful
  • 4.6
  • (236)

Aug 22, 2022 | 10:00 AM EDT

Negotiation Skills
  • 4.1
  • (11)

Aug 22, 2022 | 10:00 AM EDT

Fraud Update - Latest
  • 4.6
  • (165)

Aug 22, 2022 | 11:00 AM EDT

7 Reasons to Not Fear Retirement Planning
  • 4.0
  • (5)

Aug 22, 2022 | 11:30 AM EDT

We use cookies to make your experience on this website better