Kevin O’Donnell is Market Compliance Manager at the Health Products Regulatory Authority (HPRA, formerly known as the Irish Medicines Board), in Dublin, Ireland. He has been with the HPRA/IMB since 2001 and is a Senior GMP Inspector. He is also responsible for a number of compliance-related programmes at the HPRA, including the Quality Defect and Recall programme, the Sampling and Analysis programme, and the Advertising Compliance programme. He obtained his PhD in the field of Quality Risk Management (QRM) from the Dublin Institute of Technology in 2008. He is currently Chair of the PIC/S Expert Circle on QRM.
Deirdre Tobin has worked in the Quality Organisation in MSD Brinny, Cork, Ireland for 21 years. Currently, she works in the role of Global Biologics and Sterile EU Regional Compliance Lead where she holds responsibility for supporting all Quality Assurance and GMP compliance activities relating to the manufacture of pharmaceutical, biologics and vaccines to ensure compliance with all applicable regulations and specifications. Prior to this she has held various positions including Quality Risk Management (QRM) Risk Lead, GMP Site Auditor, Supplier and Contractor Management Oversight, and managed QA functions including QMS/Management Review structures, inspection management, documentation, stability programs, annual product reviews, and investigation management. She holds a degree in Biochemistry from University College Cork and a Post Graduate Diploma in Leadership from the University of Limerick.
Stephanie Butler is currently a Director and QP within the Quality Organisation at Jazz Pharmaceuticals in Dublin, with specific responsibility for Large Molecule development. Prior to Jazz, she has worked in Pfizer, Wyeth, Icon Clinical Research and Warner Lambert in various Quality roles including QP, QA Operations, Quality Systems, Project Management and QC Chemistry. While QS Manager at Pfizer Grange Castle, Dublin, Stephanie implemented QRM at the site. She holds a BSc in Biotech, an MSc, Software Eng Cert, PMP and P.Grad Dip in Pharmaceutical Manufacturing. She has over 20 years’ experience in the Biotech and Pharmaceutical Industry.
Ghada Haddad is currently an Executive Director, leading the Global cGMP and Compliance Auditing Organization at Merck & Company. Prior to that she was the Head of the Global Quality Risk Management Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries in the areas of Quality Risk Management (QRM), Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, change control and validation. Haddad was the chair of the Paradigm Change in Manufacturing (PCMO) initiative: QRM in Packaging and Labeling, QRM for the Design, Qualification, and Operation of Manufacturing Systems task forces, co-chaired the Aging Facilities Points to Consider and co-chaired the 2018 and 2019 Annual PDA Conferences and the 2019 PDA Quality Week. She is also a faculty member for PDA’s Training and Research Institute and a Science Advisory Board member and a member of the PDA Board of Directors.
Donal Kelleher is currently an Executive Director, Operations and leads the External Manufacturing Team responsible for Large Molecule Drug Product (Biologics & Vaccines) at MSD. Prior to that he has held a number of positions at the MSD Brinny site in Cork. These positions included Site Quality Head, Sterile Manufacturing Director, Engineering Director and Capital Projects Lead. He holds a degree in Chemical Engineering and is a certified Project Management Professional (PMP) as well as a Chartered Engineer (CEng). He has over 24 years of experience working in the Biotech and Pharmaceutical Industries.