The course is divided into one block of 4 days of lectures in a Dublin venue and 2 days of practical auditing experience in an auditing facility in Dublin. Delegates can choose to attend all six days or just particular days that are specific to their requirements. However to attend the site visits on the final two days, it is necessary that delegates first complete days 1-4.

Assessment: 

To pass the module, candidates must complete an online exam (at the end of the course at UCC).

Who teaches this course: 

Stan O’Neill is the Managing Director of The Compliance Group, having previously worked as a Qualifed Person, and then as a Senior Inspector with the Irish Medicines Board, (IMB) now the Health Products Regulatory Agency (HPRA).

Catherine McHugh is the owner of Imbolc Pharma Consulting, having previously worked as an Executive Pharmaceutical Assessor with the Health Products Regulatory Agency (HPRA) and has extensive Pharma consulting experience. 

Paula Dillon An ex-Inspector with the Irish Medicines Board, (IMB) now the Health Products Regulatory Agency (HPRA) and over 9 years of experience in the regulation of controlled drugs and GDP, Paula has represented Ireland at European and International level, including as a member of the GDP Drafting Group which was responsible for establishing the new GDP Guidelines.

Kevin Sweeney is a Senior Regulatory Consultant with The Compliance Group, having previously served in the Irish Army and as a Detective and Sergeant in An Garda Síochána. Kevin holds a PhD in Interview Techniques and specialises in fraud detection.