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Preparing for and Surviving an FDA Inspection Course Offered

The Center for Professional Advancement presents Preparing for and Surviving an FDA Inspection, October 5-6, 2011 in New Brunswick, NJ, which will provide a background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections, i.e. pre-approval inspections (PAI), routine GMP inspections, bioresearch monitoring inspections, quality systems inspections techniques (QSIT) applied to medical device companies and system-based inspections program applied to drug companies. A detailed description of the six systems will be provided.

The course offers methodologies and techniques on:
- How a firm should prepare for an FDA inspection
- Ways to train employees in view of the inspection
- How to ensure that required documentation is in place
- How to interact with the investigator — Do’s and Don’ts
- What companies should do when the inspection ends
- How to reply to 483s and warning letters
- Legal implications of non-compliance
- Post inspection actions

Upon completing this course, you will be able to:
* Demonstrate practical insight into the FDA inspection process
* Identify what the inspectors expect to see when they perform pre-approval and routine GMP inspections as well as bioresearch monitoring inspections
* Acquire hands-on strategies and techniques on the types of internal training, procedures and documentation programs your company should have in place in order to ensure a successful outcome of an FDA inspection.

Register here and use Priority Code 2055 when registering.

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