Curriculum Details
The FDA Inspection Training course is created to give participants a comprehension of the objectives, methods, and issues that FDA inspectors focus on, as well as the skills necessary to prepare for, handle, and manage those inspections at pharmaceutical plants.
This course's additional advantages include discussion of:
FDA's inspection power, expectations, and mission
GMP Summary
Regulatory inspections anticipated
Recalls, 483s, warning letters, and other possible measures
Specifics of the FDA inspection procedure and investigators' methodology
FDA inspections are subject to 21 CFR rules and guidance documents.
Various inspections
Planning for inspection readiness, including roles and responsibilities
What to do when the FDA inspects you
Guidelines for conducting interviews and conducting inspections
Agreement on Bilateral Agreements and concurrent procedures with numerous international regulatory organizations
How to react to FDA inspection results and begin creating and carrying out a comprehensive remedial plan
Actively learn about FDA inspections through presentations, discussions, and hands-on exercises with an instructor who has over 20 years of actual regulatory compliance and enforcement experience with the quality control certification.
Who ought to attend
All professionals in the FDA-regulated industries will receive the knowledge and tools they need to get ready for and manage FDA Inspection Training.
The following disciplines benefit most from the course:
Regulatory affairs managers/directors and quality assurance auditors
Employing consultants or contractors to assist businesses with inspection preparation
Management of Documents
Executive and Plant Management
All personnel who might deal with FDA inspectors or take part in an inspection
Anyone interested in finding out more information about FDA inspections
The goal of the FDA Inspection Training course is to help students successfully prepare for and through an FDA inspection. After finishing the course, you will:
Recognize how the FDA regulates inspections and visits and its guiding principles.
Recognize the contrasts between the FDA's "systems approach" and the more conventional "issues" approach to inspections with pharmacovigilance training.
Create plans for preparing for and handling FDA inspections.
In preparation for FDA inspections, learn how to perform a self-inspection.
Join the World Compliance Seminars project program of North Carolina, USA, and know all the things.
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