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
-
In-house
projects will be used to demonstrate and practice the skills and principles
of this class.
-
The optional final exam is approximately 25 questions.
-
Each student receives a student guide containing a representation of the program’s
slides and graphics with space provided for note taking.
-
This class can accommodate up to 25 people.
-
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 415.487.3500.
For
a prompt reply to requests and questions: 415.487.3500 |
allan.dewes@skillsplusinc.com
| Fax: 415.487.1926
©2011 SkillsPlus
International Inc.
| 