What to expect and how to prepare for FDA Inspection

Venue: Hilton Garden Inn

Location: Montreal, Quebec, Canada

Event Date/Time: May 26, 2010 End Date/Time: May 27, 2010
Registration Date: May 26, 2010
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A Two-day comprehensive and interactive program with case studies on:
Authority for FDA Inspections
Legal scope and limits of FDA inspections
Current FDA Positioning / ‘Threats’
Types of Inspection
How to get a quick Assessment of a Company State of Compliance
Preparing for a GMP Inspection
Auditing Your Company to prepare for international Inspections
Industry Best Practices for Managing Inspections
Fundamentals of a Systems-Based Inspection
Implement and Manage a Systems-Based Approach by implementing complaint systems
Before the Inspection
Preparing for the PAI
How to Respond to FDA Observations, and Pitfalls to Avoid
Basic survival rules
Prime Inspection Targets
Post Inspection Activities: Responding to 483s and Warning Letters
Further FDA Measures - When not meeting the requirements
Responding to 483 observations
The content of FDA Warning Letters
Course Overview

The US FDA Inspection is the last major regulatory hurdle prior to a product launch in the United States. The USA FDA inspection is a very important milestone in any Pharmaceutical company’s lifecycle. A successful inspection opens the door or retains access to one of the world’s most lucrative markets. When your PAI is unsuccessful, the inspection can seriously damage the reputation of the company which may result in penalties such as Warning Letters, and Import Restrictions. Further action such as severe fines and Consent decrees can follow. These measures can seriously affect the viability of the company.

Knowing what to expect, what FDA expects, common pitfalls, how to prepare employees and handle your response will help minimize the risks and improve the outcome of this unavoidable, sometimes challenging experience.

This two-day course will provide practical advice regarding how to prepare for FDA inspections so that your facility will pass with flying colors. The participants will also review high risk systems using the FDA’s emphasis on a risk-based approach, and also analyze each of the systems as defined by FDA both from the new pharmaceutical manufacturing systems as well as the inspectional QSIT (Quality System Inspection Technique) approach.


Montreal Airport 7880 Côte de Liesse St. Laurent, Montreal, Quebec, Canada H4T 1E7