Who should attend
About warning letter
This online training is to provide participants with an understanding of 483 Observations and Warning Letters in Pharmaceutical, Biopharmaceutical and Medical Devices Industry. The course provides understanding on 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
Key features of the course
- 24×7 Online Access. Therefore, access the course anytime from anywhere across globe.
- Students can download the course materials from dashboard. Hence, it helps them to study offline even after completion of the course.
- Access the e-lectures, case studies, self assessment modules and practical sessions through personalized web page.
- Moreover, final examination is online. Hence student can attend the final examination own convenient date and time.
What is Form 483 of USFDA? Its significance.
Why FDA issues form 483?
Recent trends in form 483
How to handle/respond to form 483?
Difference between Warning Letter and Form 483
Introduction and detailed discussion on CAPA.
Importance of handling CAPA in handling form 483
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
Importance of SOP and SOP Management System for effectiveness of plant
Practical cases of warning letter
Anyone who want to enhance knowledge about data integrity and get certified, can attend the course.
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.
Who will Benefit:
- Person working in the pharmaceutical manufacturing department / F&D personnel
- Regulatory Affairs personnel
- Research and Development personnel
- Quality Assurance & Control personnel
- Development and Preparation of Submission Materials
- Strategic management personnel
- Personnel who involved in internal audit.
- Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
- You will also eligible to receive the course study modules, which you can download by login to your course page.
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What is data integrity issues in pharmaceutical, biopharmaceutical and medical devices industry?
Data integrity is the maintenance and the assurance of the accuracy and consistency of data over its entire life-cycle. It’s a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data.
About data integrity >> Learn more