In-Depth Functional and System Requirements for Computer Systems Regulated by FDA 1.5 Credits 1.5 Credits
Learning mode
Computer System Validation (CSV) has been regulated by FDA for more than
35 years, as it relates to systems used in the manufacture, testing,
distribution, and management of a product in the pharmaceutical, biotechnology,
medical device, tobacco, and related industries. The requirements phase of the
CSV process is a key aspect of validating a system by providing the functions
and features the user will require to perform their operations.
This CPE course will focus on the key aspects
of requirements development and management, including best practices and
principles for handling this key component of project work in an FDA-regulated
environment (i.e., the system “touches” product during the manufacturing,
testing, or distribution of the product, or any other functional
activity).
The material will include the various aspects of how to develop requirements,
and the result will be a prescriptive approach to helping teams and individuals
reach a higher level of compliance. It will also guide how to keep costs low
and avoid “scope creep,” which can lengthen the time and require more money to
achieve.
Requirements include both functional and non-functional, or system
requirements. We’ll describe the differences and elaborate on the key
characteristics of a well-written requirement. The approach includes
determining risk at the requirement level, providing a risk rating for each
that can be used to determine the type and level of testing required.
Requirements at a high level should be documented using business
terminology to describe the intended use of the system. The high-level
requirements are then used as a basis for developing the unique functional
requirements and non-functional, or system requirements. Requirements will be
mapped to one or more test script(s) that will be executed to prove the
requirement is met.
This CPE webinar will help you to learn about the best practices for preparing detailed requirements during CSV, including the acceptance criteria that must be met to assure the requirement is proven through testing.
| License details | Credits | Status |
|---|---|---|
| Information Technology for Certified Public Accountants (CPA-US) | 1.5 CPE | Approved |
| Certified Information Technology Professionals (CITP) | 1.5 CPD | Eligible |
| Certified Information Systems Auditor (CISA) | 1.5 CPE | Eligible |
| Certified in Risk and Information System Control (CRISC) | 1.5 CPE | Eligible |
| Certified Wealth Strategist (CWS) | 1.5 CE | Eligible |
| Certified Fiduciary and Investment Risk Specialist (CFIRS) | 1.5 CE | Eligible |
| License details | Credits | Status |
|---|---|---|
| Information Technology for Certified Public Accountants (CPA-US) | 1.5 CPE | Approved |
| Certified Information Technology Professionals (CITP) | 1.5 CPD | Eligible |
| Certified Information Systems Auditor (CISA) | 1.5 CPE | Eligible |
| Certified in Risk and Information System Control (CRISC) | 1.5 CPE | Eligible |
| Certified Wealth Strategist (CWS) | 1.5 CE | Eligible |
| Certified Fiduciary and Investment Risk Specialist (CFIRS) | 1.5 CE | Eligible |
Credits
1.5
Course Level
Basic
Instructional Method
QAS Self Study
Group Internet Based
Pre-requisites
None
Advance Preparation
None
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.
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.
What is Self Study (QAS)?
Self Study QAS (Quality Assurance Service) is a NASBA and other regulatory bodies approved program designed for Professionals to complete their Continuing Professional Education credits through self-paced, interactive courses that meet the highest standards of quality and compliance. We are approved by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies.
How do I earn CPE credits through self-study?
To earn CPE credits, you must complete the self-study course, pass the required assessments, and submit the necessary documentation. Credits are awarded based on the completion of course hours and successfully passing the assessments.
Are the self-study courses approved by NASBA and other regulatory bodies?
Yes, all our self-study courses are approved by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies, ensuring they meet the rigorous standards for quality and educational content set by these organizations.
What are the requirements to maintain compliance with self-study courses?
To maintain compliance, you must follow the guidelines set by NASBA and other regulatory bodies, which include completing the course within the specified timeframe, passing the assessments, and keeping accurate records of your learning activities.
How can I access my course completion certificates?
After successfully completing a self-study course and passing the assessments, you can access and download your course completion certificates from your account dashboard on our platform. These certificates are recognized by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies for compliance and reporting purposes.
How are credits reported to governing bodies?
We issue instant credit certificates, ensuring they are valid for presentation to governing bodies. Typically, we report IRS, CTEC, CFP, IDFP, IWI, VBOA Ethics credits within 7 days – the fastest in the industry.
What is a Live Webinar Group Internet-Based Credit?
A Live Webinar Group Internet-Based Credit is an interactive, real-time online seminar where professionals can earn Continuing Education credits by participating in live sessions led by experts in various fields. These sessions meet the standards set by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies.
How do I earn credits through live webinars?
To earn credits, you must attend the entire live webinar, actively participate in any polls or questions, and complete any required evaluations or assessments. Credits are awarded based on your attendance and participation in the live session.
Are the live webinars approved by NASBA and other regulatory bodies?
Yes, all our live webinars are approved by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies, ensuring they meet the high standards for quality, interactivity, and educational content set by these organizations.
What are the requirements to maintain compliance with live webinar courses?
To maintain compliance, you must adhere to the guidelines set by NASBA and other regulatory bodies, which include attending the full duration of the webinar, participating in interactive elements, and completing any post-webinar evaluations or assessments.
How can I access my webinar completion certificates?
After successfully attending a live webinar and fulfilling all participation requirements, you can access and download your completion certificates from your account dashboard on our platform. These certificates are recognized by NASBA, IRS, CFP Board, HRCI, SHRM, Payroll Org, FP Canada, and 25+ other regulatory bodies for compliance and reporting purposes.
How are credits reported to governing bodies?
We issue instant credit certificates, ensuring they are valid for presentation to governing bodies. Typically, we report IRS, CTEC, CFP, IDFP, IWI, VBOA Ethics credits within 7 days – the fastest in the industry.
MR
instructor appeared to be an expert in this area .. great info
May 09, 09:00 AM ET
May 09, 10:00 AM ET
May 09, 10:00 AM ET
May 09, 11:30 AM ET
May 09, 12:00 PM ET
May 09, 01:00 PM ET
Inclusions
Multiple Credits
Earn continuing education credits with flexibility. Choose from live webinars, on-demand courses, e-books, or podcasts to fit your learning style and schedule.
Certifications & Reporting
We issue instant credit certificates, ensuring they are valid for presentation to governing bodies. Typically, we report IRS, CTEC, CFP, IDFP, IWI, VBOA Ethics credits within 7 days - fastest in the industry.
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