A Regulatory Inspection - Active Pharmaceutical Ingredients (APIs)
Also available: A Regulatory Inspection - Dosage Form
Regulatory authority inspections are a part of life in the pharmaceutical industry and the successful outcome of a regulatory inspection cannot be over emphasised
It is vital that a regulatory inspection runs smoothly and much will depend on the co-operation of all personnel who may be involved. They need to know who the inspectors are and the reason for the inspection.
This training DVD is designed for all personnel on site who are not directly involved in the inspection procedure, but nevertheless may come into contact with the inspectors.
- It gives general background information on the role of regulatory authorities, with particular reference to the FDA.
- It explains the purpose of an inspection, the need for preparedness and what to expect when the inspectors arrive on site.
- It provides suitable responses to some typical questions when being interviewed.
- It gives some useful do's and don'ts that will help to avoid a potentially awkward situation developing during the course of an inspection.
On completion the trainee should have the confidence to know the correct way to react in the presence of an inspector, which will help to achieve a satisfactory outcome to the inspection.