Pre-Approval Inspection Overview

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A beginner-friendly course to help you understand the what and why behind Pre-Approval Inspections

Our initial e-learning training course on Pre-Approval Inspections (PAIs) and why they occur will help you better understand the importance of PAIs, both for the Food and Drug Administration and an organization. We also introduce the types of inspections that are performed, why they are performed, and some of the ways the FDA ensures the ongoing safety and quality of drug products.

This course will thoroughly define the PAI and identify the types of applications that go before the FDA for approval. The course also details how all aspects of an application, all establishments named in an application, and all areas of an organization, are within the scope of a PAI. Additional topics include a discussion on the various triggers for a PAI, with a focus on the primary areas of risk that can trigger a PAI.

Throughout this course, we will equip you with a good understanding of the reasons PAIs occur, and the importance of them for both the FDA and your organization.

Our Training Approach

Our team of expert consultants and trainers has designed online training courses to help you understand the fundamentals of PAIs so that you can ensure you have the foundation needed to help your organization be successful. By utilizing an online, self-paced platform, you can complete the training when it is convenient for you.

After purchasing this course, you will get access to course materials in the online portal within 1 business day.

What You Get

Unlimited access to self-paced, online training module that includes learning retention exercises after completion of key topics and a personalized certificate of completion at the conclusion of the course.

Who Should Attend Compliance Auditing Training?

This course is recommended for all GxP employees of an organization planning for FDA approval of their product, as the entire organization has a role and should understand PAIs.

Materials Provided:
Certificate of Completion

Prerequisites:

None. This course requires you to have internet access. Upon registration, you will be sent access to the course platform to create your account and begin the course.

Course Number: PAI101

Duration: Self-paced online course, approximately 45 minutes

Cost: $50 per student

Group Pricing: For groups of 10 or more, please contact us for pricing.

We Are Offering This Course on the Following Dates: