USFDA Inspection Form 482, Form 483 & Form 484
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- Course level: All Levels
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.
9 Courses
2336 students
Free
Material Includes
- 1 Learning Video
- Course Certificate
Enrolment validity: 29 days
Tags
Target Audience
- Pharma Production
- Quality Control
- Pharma Engineering
- Quality Assurence
