Competent Authority inspections / Notified Body audits

Support in the preparation and hosting of Competent Authority inspections or Notified Body certification audits by;

• assessing the GxP Quality Management System including advise on the remediation of the identified gaps,
• Training key personnel involved in the inspection / audit on the Do’s and Dont’s,
• Providing advice on general aspects of the organisation and management of the inspection / audit (e.g. agenda, presentations, tour through facilities, communication during inspection/audit),
• Providing support in the formulation of adequate responses to the reported observations.