EU Directives and Inspection Readiness

The EU has strict requirements for the manufacture and supply of medicinal products, which are defined in EU directives and GMP guides. To confirm that these requirements are being complied with, manufactures and suppliers are regularly inspected. If significant deficiencies are identified during inspections, the company may face sanctions and could even be barred from supplying product. Upon completion of this course, you will be able to identify the regulatory background regarding EU inspections, the expectations inspectors may have, and how to prepare for inspections.

After this course learners will be able to identify the regulatory basis and scope of inspections. identify how inspections are performed. identify how you should prepare for them.