Overview:
FDA's inspection program follows well-established procedures and conducts the inspections with as much consistency as possible. FDA trains its investigators from day one. During the first six months, they attend extensive classroom and hands on training. FDA investigators learn basic skills. As time goes on, special training is given and the field staff use detailed reference materials to guide their thinking, actions, decisions and conclusions. If you understand FDA's management of its investigators and inspectional process, you can keep your establishment ahead of a needless regulatory disaster. FDA conducts inspections with standard operating procedures and detailed information on how to handle almost any situation the FDA investigator may face. The course will let you see inside an FDA investigator's mind set and what the agency will do when it evaluates what the investigator says and documents. What the investigator does and what FDA does are not mysteries, they just seem like it.
Why should you attend:
"Hi, I'm from the FDA and here to conduct an inspection." What is the first thing you do? Ring a fire alarm, close down for the day (some firms have) or do you follow well-planned protocol. You think, "Why is FDA here? Are we in trouble?" Are you prepared to talk about the trouble you know you have with FDA regulations or is your plan of action to cross your fingers.
We all know that a bad FDA inspection has immediate and long-term consequences. The cost of fixing your problems, the bad public relations, upset customers and future business plans can be set into a downward spiral. If you do not understand what FDA is doing or thinking, how can you expect to deal successfully with FDA? If you don't know how to anticipate an investigator's actions or follow their train of thought, you will not be able to mitigate the effect of inspectional findings.
"Is FDA going to send us a Warning Letter?" You can make a reasonable prediction if you understand your inspectional results and how FDA will "grade" it. The tools are available.
Areas Covered in the Session:
FDA legal authority
Types of inspections
FDA investigator training
FDA's written procedures, policy and operations guide
Industry inspection protocol
What to do and not do during an inspection
Form FDA 483 response
Warning Letter response
Enforcement
Who will benefit:
Regulatory Affairs
Quality Assurance
Manufacturing
Agenda
Day One
Lecture 1: FDA Inspection authority
FDA Inspection authority
Inspectional refusal prohibition
Lecture 2: Types of Inspections: purpose, scope and scrutiny
Comprehensive GMP
Abbreviated GMP
District or Center Directed
Regulatory Follow-up
Surveillance
Limited
For Cause
Lecture 3: Impact on you during and after inspection
How to interact with the FDA investigator
What not to say and do
Your protocol
Mismanagement of the inspection
Lecture 4: FDA Investigator Training - This is what they are thinking
On the job training and supervision
Technical, classroom and mock inspections
Evidence development to tell the story
Physical and documentary samples of your violations
Writing reports, inspectional observations and sample documentation
Physical threats and assault
Lecture 5: Investigations Operations Manual
Procedures and technical guidance. FDA's rules for themselves
FDA organization chart "in the field." Who is watching you?
Compliance Programs
Section III - the inspection / specific issues
Section V - the regulatory response / risk assessment
Lecture 6: Investigations Operations Manual (continued)
Mock "Limited" inspection
Writing inspectional observations (Form FDA 483)
Writing establishment inspection reports
Evidence documentation and custody
Day Two
Lecture 1: FDA Form 483 - List of objectionable conditions, aka list of observations
Purpose
Format / organization
Managing 483 observations during the inspection
Responding to 483 observations during "discussion with management"
What it means
How to manage the discussion
How to challenge a 483 observation
What to say and not say
Lecture 2: Your written response to a 483
Understanding the 483 - using an FDA issued 483
Time deadlines
Strategy for corrections and corrective action
Evidence of corrections and corrective action
Empty promises
Lecture 3: FDA Warning Letter - advisory of possible legal action
FDA Warning Letter procedures
Responding to a Warning Letter - in 15 working days.
Group Hypothetical Warning Letter Response - in 10 minutes
Lecture 4: FDA Enforcement Actions
Judicial
Seizure
Injunction
Prosecution
Monetary penalties
Administrative
Import / Export
Government contracts
Other government agency advisories
Fines
Premarket holds
Speaker:<span color#333333"="" style="box-sizing: border-box;">
Casper (Cap) Uldriks through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. As an investigator, he was responsible for countless 483s, scores of Warning Letters, injunctions, individual seizures, mass seizures and was coined by industry as FDA's "Darth Vader." He inspected foods, drugs, methadone clinics and clinical investigators, but specialized in the FDA's medical device program. He served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health.
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