TypeOnline Course
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Admission Process

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Certificate Course in 483 Observation by USFDA & it's implications

This course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspections, and the tool to manage those inspections in the field of pharmaceuticals.

This e-learning course provide comprehensive idea about the following:

  • FDA as regulatory body and process including 483s, Warning Letters, recalls, and other potential actions
  • The FDA inspection process and approach
  • Corrective Actions and Preventive Action (CAPA)
  • Flow of handling of warning letter from company side (who received warning letter)
  • Follow up inspections
  • How to respond to inspection and audit results

Who should attend?

This is a practical, hands-on course designed to provide pharmaceutical, comprehensive real life work experience to professionals with the information and tools they require to prepare for and manage an FDA inspection. The course is ideal for those who are working in Regulatory, Quality Assurance, Quality Control, Production Department.[/gdlr_tab]


3 Days

Course Deliverables

  • Upon admission you will be providing the user id and password to access all the content online.
  • You will also be receiving the soft copy of the e-module (which you can download from your dashboard).
Section 1Course Lectures
Lecture 1Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter [Multiple Lectures] 
Lecture 2Data Integrity issues in Pharmaceutical Industry [Related to Warning Letter]
Lecture 3Electronic Batch Record for effective compliance management | Key Understanding | Functionalities | Importance in managing data integrity