In-Depth Testing of Computer Systems Regulated by FDA

Course Description
Course Qualification
Presenter
FAQ

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 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 CPE course, we will also 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 titles of ISACA who want to understand In-Depth Testing of Computer Systems Regulated by FDA.

Who Should Attend?

Assistant Controllers
CEO
Certified Information Technology Professionals
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 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.
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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.
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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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