Best Practices in Preparation for an FDA Computer System Audit 1.5 Credits
Select your learning mode
As a “GxP” system, following Good Manufacturing, Laboratory, and Clinical Practices, the computer system must be validated following FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.
This CPE webinar will focus on the most important key areas, including data security and data integrity.
Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.
In preparation for an audit, it is important to assess the documentation that was prepared when each GxP system was validated to identify and remediate any gaps or issues. The FDA contact person(s) should be able to tell the story of how each system came into production in a validated state and how each system is maintained in that validated state with the data integrity assured.
It’s important to have the right resources and understanding of the process before any inspection. Having the validation information available and key resources who can speak to various components of it is critical and should be arranged in advance.
This online CPE webinar on Information Technology will help you learn some tips based on real FDA inspections.
Enter your qualification details to ensure this course is counted toward your compliance.
Add your qualification details to easily track your compliance. You can also add multiple qualifications for comprehensive coverage.
Credits
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.
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.
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.
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.
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.
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.
Dec 12, 11:30 AM ET
Dec 12, 12:30 PM ET
Dec 13, 09:00 AM ET
Dec 13, 10:00 AM ET
Dec 13, 11:00 AM ET
Dec 13, 01:30 PM ET
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.
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 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.
Stay current with our automated reminder system. Receive timely alerts for your CPE requirements, ensuring you never miss a deadline.
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.
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.
This course is included with,
Gain access to everything required for compliance, skill enhancement, and staying ahead of industry trends—all included in the Individual subscription. Here’s what you get:
Pre-selected courses for quick compliance
Connect with like-minded professionals on Teams.
Trusted by 250,000+ Professionals
