for Enterprise Subscriptions
$25/user
(Minimum 10 users)
$199/user
(Minimum 3 users)
You have Not Selected the Monthly or Annual Plan
Create your Free Account | Get Unlimited Access only @$199/Year ( View Details )
Trusted by 250,000+ Professionals for Continuing Education
Already have an account? Log In
To Continue using Trial, please verify your email address
You can cancel anytime during your trial period.
Trusted by 250,000+ Professionals
Steven was knowledgeable and thorough in his information about the product and what is offered. He was empathetic to my situation. He went above and beyond answering all of my many questions. Excellent service!
Great service and very patient as I asked several questions. Steven answered all my questions and helped me make the right decision in my subscription purchase. Thank you.
It is what it advertised to be. Professional quality training and CPE tracking and certificates; systems knows AZ CPA CPE requirements and categories. I've needed help on several occasions and the assistance was quick and effective; however, there were some problems with data entry. The assistance sometimes asks for input, but when I try to type it is dissallowed for some reason. On several occasions I had to close the popup to get it out of my way.
Great customer service. Classes are pertinent. Great value
Select the topics of your interest to receive Webinars/Virtual Events/E-Books/Podcasts of your interest.
Reviewed
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 and 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 information technology 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.
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.
Duration
Course Level
Instructional Method
Pre-requisites
Advance Preparation
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.
17 Ratings
Excellent
11
Very Good
6
Average
0
Poor
0
Terrible
0
MC
Dec 5th, 2023
great delivery of content
EL
Oct 30th, 2023
Great deeper dive on the FDA's processes shifting their framewrok towards QSR
Access to 12000+ Hours of Continuing Education Approved Content Know More
Subscribe to AccessCPE
General
CPD
CE
Your inquiry has been received. We will notify you once this webinar is available
CloseThank you for subscribing 7 Days Free Trial.
Experience myCPE at its best! Upgrade your browser for a more interactive, user-friendly interface, and stay ahead in your professional development journey.
Upgrade NowWe were looking so hard for you now that you are finally here, So would you tell us how you found out about us?
Thank you for submitting your inquiry! We will contact you soon.
Close