Audits preparation / Inspection readiness
DADA can assist you in preparing for an inspection. Our Pharmacovigilance inspection readiness training aims to ensure that your staff will know what to expect in the event of a pharmacovigilance inspection by a competent authority as well as how to ensure that they have the data at hand when such an inspection is carried out and advise on inspection activities, coupled with one-to-one training on interview techniques for all your inspector-facing staff. DADA has been involved in several Health Authority inspections of their client’s pharmacovigilance system and has implemented their experiences into practice-based inspection readiness training.
After the audit, DADA may be involved in drafting the response to an audit report with adverse findings following competent authority inspections or resulting from independent audits of pharmacovigilance systems. DADA assists in determining if the findings result from underlying problems or from isolated events. The response to the findings is crucial in ensuring that suitable remedies – with achievable commitments – are offered. DADA can assist in the implementation of a corrective and preventive action plan.
Clients who have outsourced the majority or all of their pharmacovigilance activities to DADA profit from the expertise and guidance DADA can offer them during these scrutinizing investigations to pass these inspections uneventfully.