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 MCQ exam (at the end of the course at UCC) and submit a 1,500 essay on Pharmaceutical auditing

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).

Dairine Dempsey is the Owner of Dairine Dempsey Consulting, having previously worked as a Senior Regulator in the area of pharmacovigilance, herbal medicines and pharmaceutical assessment with the Irish Medicines Board, (IMB) now the Health Products Regulatory Agency (HPRA).

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.

Denise Coakley is a Senior Regulatory Consultant with The Compliance Group, having previously worked in the Irish Medicines Board (IMB), now the Health Products Regulatory Agency (HPRA) as a GMP Inspector. She has worked in the pharmaceutical and biopharmaceutical industry, including laboratories, quality, validation, clinical, project management and QP.

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.

Dearbhla Byrne  has worked in the Pharma and Biopharma industry for over 20 years across different departments and held roles in QA, QC, QP, NPI and validation. An ex-GMP Inspector with the Health Products Regulatory Agency (HPRA). A registered subject matter expert for biotechnology with the European Medicines Agency. Experience in the inspection of sterile, non-sterile, biotech, IMP and ATMP manufacturing facilities as well as contract laboratories, gamma irradiation, ETO and compounding facilities