Pre-Approval Inspection Behaviors & What to Expect

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Learn what to expect during a PAI so you can be prepared

Pre-Approval Inspections (PAIs) are a critical step in the product lifecycle and they cannot be skipped. If you want your product approved by the FDA, a PAI is the key to getting your product to the market. Our compliance experts have developed an online course that can help you prepare for what you can expect during a PAI and guidance on ways to best prepare your organization for the inspection.

Topics covered during this course include:

  • The importance of developing a strategy for an upcoming inspection
  • Preparing the team and site for inspectors
  • The typical structure of a Pre-Approval Inspection
  • Details on each component of the typical PAI
  • Emphasis on the importance of handling inspector(s) requests
  • Additional details on the role a Subject Matter Expert (SME) plays in the PAI
  • Emphasis on the importance of handling responses to observations and/or findings
  • Many other preparedness tips and techniques during and after the inspection

Successful completion of this course will better prepare your organization for a PAI, and help your organization identify any potential gaps to close prior to an upcoming PAI.

Our Training Approach

Our team of expert consultants and trainers has designed online training courses to help you understand the key details of PAIs so that you can ensure your organization is prepared for an upcoming inspection. 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, though highly recommend you have a basic understanding of PAI. 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: PAI102

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: