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:
Who will benefit:
Day One
Lecture 1: FDA Inspection authority
Lecture 2: Types of Inspections: purpose, scope and scrutiny
Lecture 3: Impact on you during and after inspection
Lecture 4: FDA Investigator Training - This is what they are thinking
Lecture 5: Investigations Operations Manual
Compliance Programs
Lecture 6: Investigations Operations Manual (continued)
Mock "Limited" inspection
Day Two
Lecture 1: FDA Form 483 - List of objectionable conditions, aka list of observations
Lecture 2: Your written response to a 483
Lecture 3: FDA Warning Letter - advisory of possible legal action
Group Hypothetical Warning Letter Response - in 10 minutes
Lecture 4: FDA Enforcement Actions
Casper (Cap) Uldriks
ex-FDA Expert and former Associate Center Director of CDRH, Olsson
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."
Price: $1,295.00
Quick Contact:
NetZealous BDA as GlobalCompliancePanel
USA Phone:1-800-447-9407
Fax: 302-288-6884
support@globalcompliancepanel.com
http://www.globalcompliancepanel.com
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