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Managing Your FDA Inspection: Before, During and After  

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When you interact with the FDA, you need to look at yourself through FDA’s eyes. You can understand the purpose of an inspection, what the investigator will do and what it means for you.

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Seminar Summary:

The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection. (see full course description)

 

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Training Course Syllabus:


Managing Your FDA Inspection: Before, During and After

FDA inspects many different kinds of firms. If the FDA regulates your product, they can show up at your lobby and say, “I am here to conduct an inspection.” What do you do? What have you done to prepare for an inspection? How do you deal with the investigator, including their personality? The scary part is having to explain the error of your ways to the FDA and above all, managing an administrative action, e.g., Warning Letter or Import Alert, or a legal action, e.g., civil money penalties, seizure, injunction or prosecution. This course will help you need to know and what you should do to survive an FDA inspection with the least possible pain.

The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection. There should be no surprises if you have prepared properly. Firms need to understand the details about inspectional techniques to avoid making new problems for yourself during the inspection. You can save yourself a lot of corporate misery if you know what to do before, during and after an inspection.

Learning Objectives:

FDA legal authority to inspect
Over products
Over firm’s
Scientific/clinical studies
Premarket requirements
Postmarket requirements
FDA’s annual inspection work plan
Inspection Procedures
FDA inspection Manuals
FDA Training
Documenting violations
Refusals
Human factors

Recall procedures (What FDA expects from you.)
FDA Field Office Management
FDA Center(s) Management
The firm’s job
Inspectional observations (Form FDA-483)
Responding to a 483
Responding to a Warning Letter
Recall procedures (What FDA expects from you.)
FDA Field Office Management
FDA Center(s) Management
The firm’s job
FDA enforcement actions
Follow up inspections
Foreign Inspections

Topic Background:

FDA inspections can have a big impact on a firm’s budget, public image, customers, employees and stockholders. No one wants the bad news that the FDA investigator puts on a written list of observations, aka the “483.” Your 483 is like a report card that your teacher shows to everyone else in the class. What an investigator finds pulls together many different legal, administrative and technical factors that end up showing you and the public where you stand with the FDA. Inspections cover a wide range of products and an equally broad range of establishments, so preparing for and understanding an inspection takes work that is specific to your firm.

Day 01(8:30 AM - 4:30 PM)


08.30 AM - 09.00 AM: Registration
09.00 AM: Session Start
9:00 – 10:30 a.m.
FDA Legal Authority
FDA inspection plans and risk
Preparing for an inspection
Break 10:30 – 10:45 a.m.
10:45 – 12:00 p.m.
FDA Inspection Procedures
FDA staff guidance
FDA staff training
Lunch 12:00 – 1:00 p.m.
1:00 – 2:30 p.m.
Inspection strategy and technique (cont.)
Break 2:30 p.m. – 2:45
2:45 – 4:30p.m.
Inspection strategy and technique
War rooms

Day 02(8:30 AM - 4:30 PM)


9:00 – 10:30 a.m.
Documenting violations
Collecting “samples”
Responding to inspectional observation (The “483”)
Break 10:30 – 10:45 a.m.
10:45 – 12:00 p.m.
Responding to a Warning Letter
Legal enforcement actions
Lunch 12:00 – 1:00 p.m.
1:00 – 2:30 p.m.
Recall actions and procedures
The field District Office
The Center(s)
The recalling firm
Notifying the public
Break 2:30 – 2:45 p.m.
2:45 – 3:00 p.m.
Follow up inspections
Corrective and Preventive Actions
3:00 – 4:30 p.m.
Foreign inspections
Import Alert

Seminar Summary:

The course will cover the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do and what they will cover in the inspection. (see full course description)

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