Manufacturers who market medicinal products in America, must meet the US Food and Drug Administration’s (FDA) regulatory requirements.
Organisations are periodically inspected as part of the regulatory requirements; established approved manufacturers are subject to routine cGMP audits, to ensure their produced medicine still meets patent and regulatory requirements, and is not a threat to the patient.
The internal audit process is considered a crucial corporate tool because of the FDA’s strict and stringent methods, and therefore organisations place considerable emphasis on bringing their operations up to speed for inspections.
Industrial Technology Systems Ltd (ITS) offers the following training course to help understand the requirements and the obligations they place on organisations:
An Insight into FDA Inspections Training is a one-day course, that can be undertaken on its own or as an addition to either the Introducing GMP or GMP Fast Track Fresher Programme. The course helps to build an understanding of the FDA audit process and explains how to develop internal procedures which meet regulatory compliance.