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FDA Pre-Approval Inspection

0 999
Enrolment validity: 30 days

Description

In this course learn about the Food and Drug Administration (FDA)’s Pre-Approval Inspection (PAI). The Food, Drug, and Cosmetic Act provides that FDA may approve an NDA or an ANDA only if the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug are found adequate to ensure and preserve its identity, strength, quality, and purity.

Language: English

How to Download Course certificate: Watch Video

What I will learn?

  • Pre-approval Inspection Compliance Program
  • Site Evaluation
  • When does FDA perform PAIs?

Course Curriculum

FDA Pre-Approval Inspection

  • Part 1
    09:29
  • Part 2
    10:25
  • Quiz:

Student Ratings & Reviews

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Material Includes

  • 2 Learning Video
  • 1 Quiz
  • Course Certificate

Target Audience

  • Quality Assurance
  • Quality Control
  • Pharma Professional
0 999
Enrolment validity: 30 days
0 999
Enrolment validity: 30 days

Material Includes

  • 2 Learning Video
  • 1 Quiz
  • Course Certificate

Target Audience

  • Quality Assurance
  • Quality Control
  • Pharma Professional
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