our trainers

Ita Walsh is a Senior Regulatory Consultant with The Compliance Group. Ita is a qualified pharmacist and ex-regulator in the Health Products Regulatory Authority (HPRA) in the area of pharmaceutical assessment. Ita spent over 12 years working in the pharmaceutical industry in Regulatory Affairs, Technical Services and Quality Assurance as a Qualified Person. Ita has extensive experience in quality systems, GMP, medicines regulation, medical devices and project management.

 

Bernadette O’Brien is a Senior Consultant and Qualified Person at EUPS with over 20 years’ experience in the Pharma and Biopharma industry. Bernadette has an Honours Degree in Pharmacology and a Master Degree in Business Administration. She held a number of senior quality leadership roles before being appointed as Head of Quality with responsibility for Quality Assurance, Compliance, Quality Control Chemistry, Microbiology, Regulatory Affairs and Validation. She has worked at IVAX, Teva, Genzyme and Sanofi with both clinical and commercial products, across aseptic filling, oral dose and inhalation platforms. Bernadette has extensive experience in hosting inspections with HPRA and US FDA, in addition to experience with Regulatory Inspections by CFDA, Canada, Russia, Korean, Turkey, Brazil, Japan and GCC. With expertise in Quality Systems and Operational Quality Compliance, Bernadette has a proven capability in Technical and Analytical Transfer, Product Life Cycle Management, Quality Risk Management and Human Error.

 

 

Ann is a quality professional with more than 25 years of management experience in Pharmaceutical, Medical Device and Cosmetic manufacturing. Roles to date have included responsibility for site Quality assurance, compliance, quality control, regulatory affairs, new product introduction, process transfer and scale up and validation. She has also worked in international corporate roles in the supply-chain management (due diligence auditing, GxP auditing and contractor oversight) for both clinical and commercial pharmaceutical manufacture and medical devices. She has participated in teams which have successfully passed their first GMP & GDP license applications and NDA inspections. As part of continuous improvement Ann has been involved in working on improved technical writing skills and human error reduction programs.

Product types and processes with which she is familiar include small molecule APIs, bulk drug substances, medical devices and finished pharmaceuticals and biopharmaceuticals. Dosage forms include lyophilized products, aseptic filling, liquids & tablets, creams, sachets, powders and patches.

 

 

Paula Dillion is a senior regulatory consultant with The Compliance Group specialising in the area of controlled drugs and Good Distribution Practice (GDP). Paula worked in the pharmaceutical sector before undertaking a masters degree in Forensic Science. In 2002, Paula joined the IMB as a scientific officer in the area of controlled drugs in licensing function from the transfer of the controlled drugs licensing function from the Department of Health and Children in the IMB. Within this roll she represented Ireland at meetings of the Drug Precursor Committee and Working Group on an EU level. In 2006 Paula was appointed as an inspector and was responsible for conducting both GDP and controlled drugs inspections. During this time Paula represented the IMB at PIC/S GDP Working Group meetings and at the GDP Drafting Group of the EMA, responsible for redrafting thee GDP Guidelines for which she acted as Rapporteur. During her time in the IMB, she was trained as a GMP Inspector for API manufacturing. Paula has worked as the Head of Quality for an Irish based distributor and has been the nominated Responsible Person for two wholesalers. She also holds a Master’s Degree in Industrial Pharmaceutical Science, making her eligible to act as a QP. Paula was also employed as a Quality Assurance Supervisor in an API Manufacturer.