FDA Inspections
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We also recommend: [Executive Session: What Leadership Needs to Know] [Management Session: What Every Manager Needs to Know] [Creating CGMP and QSR Responsibility and Accountability] [Meetings for Swift and Aggressive Regulatory Enforcement]

 

Surviving an FDA Inspection

 

 

Purpose

Prepare plant personnel to participate in an FDA Inspection.

 

Objectives  

1.   State acceptable behaviors during an FDA inspection.

2.   State unacceptable behaviors during an FDA inspection.

3.   Practice responding to FDA questions.

4.   Develop a plan for hosting the FDA for an inspection; job responsibilities, presenting a site overview, conducting tours with the FDA, planning for the proper space for hosting the FDA, and site rules for photocopies and photographs.

 

About the Class

  1. In-house projects will be used to demonstrate and practice the skills and principles of this class.

  2. The optional final exam is approximately 25 questions.

  3. Each student receives a student guide containing a representation of the program's slides and graphics with space provided for note taking.

  4. This class can accommodate up to 25 people.

  5. Duration: 8 hours as a minimum. Depending on the project selected, this class may take several days.

Topics

 

Introduction

1.     The authority to inspect  

 

Inspection approaches

1.     Full and abbreviated

2.     Quality Systems

3.     Inspection and risk assessment  

 

Notification

1.     Announced

2.     Unannounced

3.     Court ordered  

 

The inspection team

1.     Roles and responsibilities of team members 

Documents to help the inspection  

FDA Arrival

1.     Greeting

2.     Credentials

3.     Meeting room selection

 

Site rules

1.     Arrival

2.     Safety and security

3.     Photographs

4.     Photocopies

 

The inspection

1.     The agenda

2.     Tours

3.     Handling product

4.     Walk through audit

5.     Documentation review

6.     Close out meeting

Interacting with the FDA

1.     Seeking to understand

2.     Responding and procedures

3.     Disagreeing

4.     Supervisory intervention

5.     Leading responses

6.     Acceptable interventions

7.     "Off-the-record"

8.     Listen, understand, speak

9.     Hypothetical questions

10.  Requests for opinions

11.  Approximations  

 

Documentation control

1.     Shared

2.     Freedom of Information

3.     Confidential documents

4.     Forms and affidavits

5.     Document handling

6.     Photocopies

7.     Inspection history  

 

Samples

1.     Close out meeting

2.     Establish Inspection Report

3.     483's  

 

Inspection training

1.     Planning

2.     Preparation

3.     Communication  

The right to disagree 

Wrap Up

   

 

Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.948.5220.

 

For a prompt reply to requests and questions:  415.948.5220 |  skillsplus@aol.com    |   Fax: 954.566.5225

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