This short tutorial video shows you how to use the Phoenix® WinNonlin® Validation Suite.
As required by US FDA’s 21 CFR Part 11, International Conference on Harmonization of Technical Requirements (ICH), EudraLex Annex 11, and other regulatory agency guidance documents, computer systems used in the pharmaceutical industry, and output from software used in regulatory submissions, must be validated to assure proper performance. This necessitates companies to invest significant time and resources to manually write and perform the validation steps used in software execution.
The Phoenix® WinNonlin® Validation Suite is integrated into Phoenix and provides software validation in less than 30 minutes with non-editable PDF reports containing links to saved reference files, user output files, and difference files. Updated validation template documents are aligned with the latest regulatory guidance computer system validation such as ICH E6 Good Clinical Practice (GCP) R2 and can be readily modified to fit individual user/organizational policies and procedures.
Note: the launching of a new Certara website makes it necessary to publish a new versions of these Terms and Conditions for Certara University. The Certara "Privacy" link below has a new URL. The rest of the terms are unchanged from the previous version.
User Accounts and Registrations
The email address used for your user login must be an individual account. No sharing of user accounts between multiple individuals is allowed. Each user account (and any associated course registrations) is for a specific person, and cannot be transferred to a different individual once the course has started.
As a course registrant, you may view and read all materials related to your registered courses. However, you may not share, communicate, publish, copy or in any manner distribute to other parties the course materials, reference material provided, assignment solutions, quiz questions, exam questions, links or any other materials.
Certara retains the right to cancel sessions, if 30 calendar days before the first day of class, there are fewer than five students enrolled. Participants should wait to book nonrefundable travel until they receive confirmation from Certara that a class has sufficient registrations to proceed.
If a scheduled class is cancelled, Certara will notify enrolled students at least thirty calendar days before the first day of the scheduled class and the full cost of the course would be refunded. Certara will not be responsible for any airfare, accommodation or other costs incurred by registrants in the event a course is cancelled for any reason. If Certara cancels a course within 30 days for any unforeseen reason a full refund will be issued and airfare exchange fees may be refunded.
If you cannot attend the session for which you have enrolled, you can (1) choose a different session of the same course, (2) have another person attend in your place, or (3) you may be able to get a full or partial refund, based on the number of days prior to the session, as shown in the table.
|1-30 Calendar Days||0% Refund|
|31-59 Calendar Days||50% Refund|
|60 Calendar Days or More||100% Refund|
Live Online Courses
There are no refunds for Live Online courses. Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.
e-Learning and Certifications
There are no refunds for e-Learning courses or certifications. Course expiration dates can be found on your Dashboard.
We will send you email notifications regarding your training courses, including enrollment confirmations, purchase confirmations, and reminders of upcoming sessions. We will also send email for general announcements about the site. You can opt out of these emails if you wish (located in your profile).
Full terms and conditions applicable to this LMS are available at the Certara Legal web page.
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