TypeOnline Course
Price$90 / Rs. 5850
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Introduction

Who should attend

Course Content

Duration

Course Deliverables

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

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.

What is Form 483 of USFDA? Its significance.
Why FDA issues form 483?
Recent trends in form 483
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How to handle/respond to form 483?
Difference between Warning Letter and Form 483
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Introduction and detailed discussion on CAPA.
Importance of handling CAPA in handling form 483
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Types of USFDA warning Letter
Warning Letter – Parts and Content
Flow of handling of warning letter from company side (who received warning letter) Follow up inspections
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Importance of SOP and SOP Management System for effectiveness of plant
Practical cases of warning letter

Details understanding will be provided on the USFDA regulation for pharmaceutical and biopharmaceuticals. 

3 Days 

  • 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 Introduction & Agenda Setting
Section 2Drug Discovery and Development Process
Section 3Quality Issues: Product Recall | Market Withdrawal
Section 4Classification of Product Recall
Section 5USFDA warning Letters and Types
Section 6Types of FDA inspections
Section 7How to respond Form 483
Section 8Recent trends in form 483
Section 9CAPA
Section 10Handling of Internal Audit
Section 11SOP Management for Regulatory Perspective
Section 12Practical Case Studies
Section 13Summary