In-Depth Functional and System Requirements for Computer Systems Regulated by FDA 1.5 Credits
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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.
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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.
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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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
MC
great delivery of content
EL
Great deeper dive on the FDA's processes shifting their framewrok towards QSR
Dec 11, 09:00 AM ET
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Earn continuing education credits with flexibility. Choose from live webinars, on-demand courses, e-books, or podcasts to fit your learning style and schedule.
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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