Computer System Validation (CSV) Boot Camp – Day 1 of 3 days Intensive Training

Course Description
Course Qualification
Presenter
FAQ

Course Description

Computer system validation (CSV) is a documented process that is required by regulatory agencies around the world to verify that a computerized system does exactly what it is designed to do in a consistent and reproducible manner. These regulatory agencies require CSV processes to confirm the accuracy and integrity of data in computerized systems to ensure product safety and effectiveness.

In the United States, for example, the FDA requires pharmaceutical companies to perform CSV for systems that support the production of the following products:

Pharmaceuticals
Biologicals
Medical Devices
Blood and blood components
Human cell and tissue products
Infant Formulas

Computer system validation is required when configuring a new system or making a change in a validated system. CSV processes should be based on applicable regulations and guidance, best practices for the domain, and the characteristics of the system being validated.

Following are the major topics covered on Day 1 of this CPE Webinar on Information Technology:

FDA Compliance
Computer System Validation Methods and Models
CSV Planning
System Requirements & Design

This CPE course is designed to completely immerse you in computer system validation (CSV). It delivers comprehensive details of the regulations impacting your systems and hands-on practice writing validation documents.

During boot camp, we will explore both a traditional waterfall approach to validation and a Computer Software Assurance (CSA) approach that is supported by FDA. CSA focuses on critical thinking and may be done according to an agile methodology, using automated testing to improve the speed and quality of the validation effort. We will highlight the key differences and what must be done to succeed with either of the two methodologies.

We will also discuss industry best practices and areas of potential confusion and risk. Both compliance with data integrity and 21 CFR Part 11, FDA’s guidance on electronic records (ER) and electronic signatures (ES) will be covered.

Boot camp is tough and challenging.

It is a three-day complete immersion in the validation process. Participants will work in focused teams to complete hands-on validation activities through instruction, exercises, and case scenarios. The course moves quickly and participants will change gears often to keep interested high and accommodate multiple learning styles. A balance of instructor lectures, reading materials, exercises, and case studies keeps energy levels high and challenges the participants.

Learning Objectives

To discuss how to identify “GxP” Systems.
To study the Computer System Validation (CSV) approach based on FDA requirements.
To analyze the System Development Life Cycle (SDLC) approach to validation.
To evaluate how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
To inspect the risk-based validation techniques and how to leverage these techniques to create efficient yet compliant validation approaches.
To discuss the importance of “GxP” documentation that complies with FDA requirements.
To inspect 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.

Recommended For

This CPE webinar is recommended for CPA, CFE, CIA, CGFM, FPAC, CISA, CISM, CRISC, and all the titles of ISACA who are responsible for planning, execution, and support of computer system validation activities.

Who Should Attend?

Certified Information Technology Professionals
Certified Management Accountant (CMA)
Certified Public Accountant (CPA)
CPA (Industry)
CPA - Large Firm
CPA - Mid Size Firm
CPA - Small Firm
Entrepreneurial CPA
Young CPA

Course Qualification

Webinar Qualifies For

6 CPE Credit for Certified Fraud Examiner (CFE)
6 CPE Credit for Certified Government Financial Manager (CGFM)
6 CPD Credit for Certified Information Technology Professionals (CITP)
6 CPE Credit for Certified Internal Auditors (CIA)
6 CPE Credit of Information Technology for Certified Public Accountants (CPA-US)
6 CRE Credit for Certified Corporate FP&A Professional (FPAC)
6 CPE Credit for Certified Information Systems Auditor (CISA)
6 CE Credit for Certified Fiduciary & Investment Risk Specialist (CFIRS)
6 CE Credit for Certified Wealth Strategist (CWS)
6 General Credit for Accountant/Bookeeper
6 CPE Credit for Certified in Risk and Information System Control (CRISC)

Additional details

Course Level :

Basic
Credits :

6
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.
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.

Ratings and Review

5

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Linda Hagedorn, CISA, CDPSE, PMI-ACP

Mar 29th, 2022

I had an excellent experience in this class. The instructor is a master with her subject, and her dedication to transferring the knowledge could be felt in the room. She was enthusiastic and powerful in her delivery, and yet gracious when a word or two needed to be changed. I was very impressed with her, and delighted with the material.