FDA’s Pharmaceutical

Inspectorate
Robert Coleman
National Expert Drug Investigator
Food and Drug Administration
Certification
 Background
Certification begun in 1994
To create consistent inspectional activities
nationally through a uniformly managed
training & audit process for our
investigators.
Will proceed as long as adequate funding
and support exists.
 Purpose
Provide training to develop & maintain a
qualified & effective staff of investigators.
Provide a structured mechanism for
investigators to obtain, maintain &
consistently apply the required
competencies
Objective: Assure our Investigators continue
to have the skills & knowledge necessary to
do their jobs.
 Players
Human Resource Committee
Division of Human Resource Development
Course Advisory Committee(s)
Certification Board(s)
Performance Auditors
Certification Candidates
District Management
Office of the Director of Regional Operations
Division of Field Investigations
 Program Areas with
Certification
Medical Devices
Blood
Seafood
Drugs
 Drug Certification
Level I

Level II

Level III
 Level I

Mandatory
For all new hire investigators
Training completed in the first 12-
months.
Demonstration of competency via a
successful performance audit results in
Level I Certification.
 Level I Training
Web based training courses and OJT
experience
Classroom training courses
– Basic Food and Drug Law
– Evidence Development
– Investigative Interviewing
– Quality Auditing
 Level I Audit Criteria

First line supervisor looks for:

– General Investigational Practices
– Evidence
Recognize, Collect and Identify Appropriate
Evidence to Support Findings
– Verbal Communication
– Written Communication
– Professionalism
 Level II Drug Certification
Not mandatory
Candidate must
– Spend at least 25% of time in drug program
– Submit packet to Level II Drug Certification
Board
– Pass performance audit
– The Performance Auditor is a Board Approved FDA
employee who completed their Level II Certification
– Be recertified every 3 years (18 CEU hours)
 Level II Drug Investigator
Certification Prerequisites

Must meet Level I criteria

Required training courses
– Drug Manufacturing & Quality Control Training
Course
– Pre-Approval Inspections Training Course
– Industrial Sterilization of Drugs & Devices
Training Course
– Computer Systems Validation Training Course
– Active Pharmaceutical Ingredient Manufacturing
Training
 Level II Certification Board
National Expert
Experienced Field Investigator
Expert from CDER
Expert from CVM
Field Manager
DHRD Specialist
 Level II Audit Criteria
Compliance assessment
Evidence
Verbal Communication
Written Communication
Professionalism
 Level III Drug Certification
AKA “Pharmaceutical Inspectorate”
Not mandatory
Planning for 50 members by FY07
 Who is eligible for the PI?

FDA employees with at least 3 years of experience in

inspecting drug firms.
– ORA Field Investigators
– CDER/CVM personnel
– Investigative analysts

Certified at Level II
– Must pass a six system audit

Endorsed by District/Office management

Selected/nominated by Level III Certification Board

 How do they join?
Submit their name to their supervisor for
consideration.

Initial nomination will have concurrence from

their District management.

Submit a certification packet to the Level III

Drug Investigator Certification Board for review
and selection.

The Certification Board will screen the

applicant.
 Level III Drug Certification
Board
2 Field Investigators (National Experts)
operating at Level III
2 Experts from the CDER
2 Experts from the CVM
1 DFI Program Expert
1 ORA Field Manager from the appropriate
Field Committee
1 Representative from DHRD
 Who are the candidates?

FDA personnel (mainly Investigators) with

specialized experience & specific training in
evaluating pharmaceutical manufacturing.
Report directly to ORA District Office
management for assignments.
Spend about 80% of their time conducting
drug inspections (domestic & foreign) and
related activities.
Expected Competencies for PI
Regulating Pharmaceutical Quality and the
Relationship to FDA’s Mission
Risk Management
Advanced Quality Systems
Pharmaceutical Science
Current Regulatory Programs and
Procedures
Technology
Investigational
 Selection Criteria for the PI
Candidate demonstrates:
– Willingness to share his/her knowledge
with colleagues
– Initiative to go beyond the “expected” or
“required”
– Innate ability to separate important issues
from unimportant issues
– Currency of knowledge
– Desire to excel
 Selection Criteria for the PI
Candidates will:
– Primarily focus on conducting pharmaceutical
inspections
– Successfully meet all Level I and Level II
requirements
– Recognize when additional training is needed
– Be a recognized resource on advanced
technology or inspectional techniques
– Demonstrate effective verbal and written
communication skills
 Admission to the PI
To become a PI member the candidate
must:
– Have their packet successfully reviewed
– Pass the screening
– Pass the training
– Participate in Center details
– Pass final evaluation
What training will be provided?
First course completed in 2005
Second course scheduled in 2006
– Still under development
Some Course Agenda Items
Quality Systems & ICH Guidances
Tools Process Capability
Risk Assessment & Technology Transfer
Management CAPA
Critical Thinking PAT
Quality by Design
Design of
Experiments
 PI Course Advisory Group
ORA, CDER training manager & trainers
ORA/DFI representatives
ORA Field investigator
ORA Field Manager
CDER, CVM representatives
Others (on a course by course basis)
 PI Expectations

Seek additional activities to further their expertise.

Develop & implement formal training programs for
FDA, industry, and state/local officials.
Develop/evaluate programs, policies, or procedures
in their area of expertise.
Auditors for the Level II or III Drug Certification
programs.
Participate in professional activities that maintain,
broaden, or enhance their knowledge.
 HOW TO REACH ME
Robert C. Coleman
US FDA
60 Eighth Street, N.E.
Atlanta, Georgia 30309
USA
Tel: 404-253-1295 FAX: 404-253-1205
Email: Robert.Coleman@fda.hhs.gov