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4.67(3)

USFDA Inspection Form 482, Form 483 & Form 484

Description

During an USFDA inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements.

What will you learn

In this course, you will learn some of the following concept

  • What are USFDA Inspection Form 483, Form 482, Form 484?
  • EIR (Establishment Inspection Report)
  • OAI (Official Action Indicated)
  • NAI (No Action Indicated)
  • VAI (Voluntary Action Indicated)

Language: Hindi

How to Download Course certificate: Watch Video

Topics for this course

1 Lessons05m 45s

USFDA Inspection Form 482, Form 483 & Form 484

USFDA Inspection00:05:44

About the instructor

Dr. Satish Gupta defines himself as a Pharma-addict and has got a very strong inclination towards Pharma Education & Skilling. Qualification: MBBS & MBA Worked in Clinical Practice & Hospital Administration before moving into the Pharma space. In Pharma Industry worked in the Medical Affairs department of the companies such as MSD, Novartis & Alcon. Currently, working as Chief Operating Officer (COO) at PharmaState Academy.
4.58 (73 ratings)

9 Courses

2336 students

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Excellent

Explained in such an easy manner.

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Free

Material Includes

  • 1 Learning Video
  • Course Certificate

Enrolment validity: 29 days

Target Audience

  • Pharma Production
  • Quality Control
  • Pharma Engineering
  • Quality Assurence

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