Conference Description:

Course "Managing Your FDA Inspection: Before, During and After" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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 you should 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

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