Developing a Strategic Approach to FDA Compliance for Computer Systems 1.5 Credits 1.5 Credits
Learning mode
Effective and
compliant computer system validation is critical to any FDA-regulated
organization. During the past 30 years,
best practices have been developed and, if followed, can ensure laboratory
computer systems are validated efficiently and in compliance with FDA
regulations. This CPE webinar will
provide guidance for planning, executing, and validating a laboratory computer
system, and managing the system in a validated state through the end of the
system life cycle.
The CPE course will
address roles and responsibilities, the timing of phases and deliverables, business
process reengineering, organizational change management, change control, audit trails, training, and documentation.
You will learn what is required not only to validate your laboratory system but maintain it in a validated state until it is retired or otherwise no longer
in use.
There is an enormous
body of documentation and information available on computer system validation,
which can be overwhelming. This continuing
education course will provide a condensed overview of the practices that
deliver the best results by directing the attendees to the most critical and
cost-effective methods, techniques, and tools available.
Major areas covered in this online CPE course:
Click here for more Information on technology webinars
| License details | Credits | Status |
|---|---|---|
| Information Technology for Certified Public Accountants (CPA-US) | 1.5 CPE | Approved |
| CPA in Canada | 1.5 CPD | Eligible |
| Certified Internal Auditors (CIA) | 1.5 CPE | Eligible |
| Certified Management Accountants (CMA) | 1.5 CPE | Eligible |
| Certified Fraud Examiner (CFE) | 1.5 CPE | Eligible |
| Certified Government Financial Manager (CGFM) | 1.5 CPE | Eligible |
| Certified Information Technology Professionals (CITP) | 1.5 CPD | Eligible |
| Certified Information Systems Auditor (CISA) | 1.5 CPE | Eligible |
| Certified Information Security Manager (CISM) | 1.5 CPE | Eligible |
| Certified in Risk and Information System Control (CRISC) | 1.5 CPE | Eligible |
| Association of Chartered Certified Accountants (ACCA) | 1.5 CPD | Eligible |
| Certified Wealth Strategist (CWS) | 1.5 CE | Eligible |
| Chartered Accountant - ICAEW | 1.5 CPD | Eligible |
| Certified Fiduciary and Investment Risk Specialist (CFIRS) | 1.5 CE | Eligible |
| Certified Data Privacy Solutions Engineer (CDPSE) | 1.5 CPE | Eligible |
| Certified in the Governance of Enterprise IT (CGEIT) | 1.5 CPE | Eligible |
| Information Technology Certified Associate (ITCA) | 1.5 CPE | Eligible |
| CSX Cybersecurity Practitioner (CSX-P) | 1.5 CPE | Eligible |
| Certified In Emerging Technology (CET). | 1.5 CPE | Eligible |
| CPA - Ireland | 1.5 CPD | Eligible |
| Chartered Accountants - Scotland | 1.5 CPD | Eligible |
| Chartered Accountants - Ireland (CAI) | 1.5 CPD | Eligible |
| Certified FP&A Professional (FP&A) | 1.5 CE | Eligible |
| License details | Credits | Status |
|---|---|---|
| Information Technology for Certified Public Accountants (CPA-US) | 1.5 CPE | Approved |
| CPA in Canada | 1.5 CPD | Eligible |
| Certified Internal Auditors (CIA) | 1.5 CPE | Eligible |
| Certified Management Accountants (CMA) | 1.5 CPE | Eligible |
| Certified Fraud Examiner (CFE) | 1.5 CPE | Eligible |
| Certified Government Financial Manager (CGFM) | 1.5 CPE | Eligible |
| Certified Information Technology Professionals (CITP) | 1.5 CPD | Eligible |
| Certified Information Systems Auditor (CISA) | 1.5 CPE | Eligible |
| Certified Information Security Manager (CISM) | 1.5 CPE | Eligible |
| Certified in Risk and Information System Control (CRISC) | 1.5 CPE | Eligible |
| Association of Chartered Certified Accountants (ACCA) | 1.5 CPD | Eligible |
| Certified Wealth Strategist (CWS) | 1.5 CE | Eligible |
| Chartered Accountant - ICAEW | 1.5 CPD | Eligible |
| Certified Fiduciary and Investment Risk Specialist (CFIRS) | 1.5 CE | Eligible |
| Certified Data Privacy Solutions Engineer (CDPSE) | 1.5 CPE | Eligible |
| Certified in the Governance of Enterprise IT (CGEIT) | 1.5 CPE | Eligible |
| Information Technology Certified Associate (ITCA) | 1.5 CPE | Eligible |
| CSX Cybersecurity Practitioner (CSX-P) | 1.5 CPE | Eligible |
| Certified In Emerging Technology (CET). | 1.5 CPE | Eligible |
| CPA - Ireland | 1.5 CPD | Eligible |
| Chartered Accountants - Scotland | 1.5 CPD | Eligible |
| Chartered Accountants - Ireland (CAI) | 1.5 CPD | Eligible |
| Certified FP&A Professional (FP&A) | 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.
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.
Credit Tracker
Track and manage your compliance across all 50 states and over 100 designations. Our Credit Tracker keeps your CPE credits and compliance requirements always up-to-date.
Certificate Vault
Certificate Vault to upload, manage, and access certificates earned from various sources and an integrated credit tracker, allowing users to monitor and manage their credits conveniently for compliance.
Compliance Reminders
Stay current with our automated reminder system. Receive timely alerts for your CPE requirements, ensuring you never miss a deadline.
Mobile App Access
The myCPE Mobile App allows you to learn on the go, providing access to educational content on Android and Apple iOS devices. You can learn anytime and anywhere, making it convenient for busy schedules.
Live Support
Our support team is available via live chat, email, and phone from 9 AM to 5 PM ET. We're here to help with any questions or issues, ensuring you have a seamless experience.
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15,000+ Hrs of CPE approved Content
Largest content library covering all aspects of professional development. |
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500+ Emerging Subject Areas
Wide range of subject areas tailored to meet diverse learning needs of all the department of the firm. |
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50+ State- Specific Ethics Courses
Stay compliant with ethics requirements for every state. |
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50+ State Compliance Packages
Pre-selected courses for quick compliance, saving time and effort. |
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100+ Advanced Certification Programs
Expert-led programs to build advanced expertise and strengthen your career credentials. |
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AICPA Eligibility Programs (CFF, ABV, PFS)
Pre-Packaged Eligibility Courses for AICPA designations such as PFS, ABV, and CFF, offering CPE credits upon completion. |
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Compliance Tracker and Credit Vault
Store all your certificates in one place, stay compliance-ready with ease, and track your progress effortlessly using the built-in credit tracker. |
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Instant Certification and Fast Reporting
Instant reporting to IRS, CFP Board, and other governing bodies. |
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