as of 2018 - 12 - 03

18.I Preparing for FDA GMP inspections

18.I Preparing for FDA GMP inspections
Here you will find answers to the following questions:

What deficiencies are most often criticised by the FDA?

What areas does the FDA tend to focus on?

What roles do the members of the inspection team take on?

What are the functions of the back office and front office?

How do technical experts best prepare themselves?

How can the language barrier be overcome?

How is GMP compliance ensured in a company?

What is the best way to behave during an inspection?

What is the correct response to an FDA 485 inspection report?

What does the concluding FDA report contain?

What is the difference between a Warning Letter and an Untitled Letter?

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