OVERVIEW

FDA Inspections - What Regulators Expect and How to Prepare is organized by The Center for Professional Innovation & Education (CfPIE), Inc. and will be held from Nov 09 - 10, 2026.

Description:
This FDA inspection preparation course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical facilities.

Additional benefits of this class include discussion of:

FDA mission, expectations and inspection authority
GMP Overview
Expectations of regulatory inspections
483s, Warning Letters, recalls, and other potential actions
Details of the FDA inspection process and approach by inspectors/investigators
21 CFR regulations and Guidance Documents as they apply to FDA inspections
Types of inspections
Roles and responsibilities and planning of inspection readiness
How to manage an FDA inspection
Do's and Don'ts of interviews and the inspection process
Mutual Recognition Agreement and parallel process with other international regulatory agencies
How to respond to FDA inspection findings and start to generate and execute a detailed remediation plan
Actively learn from fellow participants and well as from an instructor who brings over 20 years of practical compliance and regulatory experience to a combination of presentation, discussion, and activities related to FDA inspections

Learning Objectives:
The course is designed to meet the objectives of preparing for – and surviving – a successful FDA inspection. Upon completion of the course you will:

Recognize the guidelines, philosophy and regulatory expectations of the FDA to inspections and visits
Comprehend the FDA "systems approach" to inspections, and the differences from the traditional "issues" approach
Develop strategies to prepare for and manage FDA inspections
Observe how to conduct a self-inspection in anticipation of FDA inspections
Have resources for reference and update
Fully understand the “do’s” and “don’ts” during an inspection
Fully understand how best to respond to FDA inspection observations