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GXP Training

our trainers

Stan O’Neill
BSc (Pharm), MPSI

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Stan O’Neill is the Managing Director of The Compliance Group. After qualifying as a Pharmacist, Stan spent over five years working in the pharmaceutical industry in Regulatory Affairs, Marketing and Quality Assurance (QP) and then joined the Irish Medicines Board (IMB), now the Health Products Regulatory Agency (HPRA), for a period of ten years. In his capacity as a Senior Inspector, he performed GMP inspections throughout the world, represented Ireland at European level for the negotiation of standards of inspection for medicinal products and trained Inspectors at Irish, European and International levels.

 

 

Richard Bierney
BSc (Hons)

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Richard Bierney is a Senior Regulatory Consultant with The Compliance Group with expertise in the practical application of the Operational Aspects of Good Manufacturing Practice. Richard has over 25 years’ experience in the Pharma and Biopharma Industry. During that time, he held a number of Quality, Operational and Leadership roles within Sanofi, Schering Plough, Amgen and Genzyme. Additionally, Richard has 2 years’ experience with the Irish Medicines Board, now the HPRA, where he was a GMP Inspector. Richard also has a demonstrated background in the use of the Continuous Improvement Tools associated with Lean as a mechanism to improving Quality and Compliance within an Organisation.

 

 

Paula Dillion

Bsc, MSc.

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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.

 

 

Kevin Sweeney
PhD, MA (Criminology)

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Kevin Sweeny is a senior regulatory consultant with The Compliance Group.
Kevin served with the Irish Army before joining An Garda Síochána where he spent over 30 years in various roles as both a detective and a sergeant. Kevin holds a Master in Criminology and a PhD in Interview Techniques. He specialises in the areas of interviewing, fraud detection and evidence collection. Kevin occupational Police Training included Criminal Assets Profiler, Anti-Counterfeiting Operations LEA, Intellectual Property Fraud Investigator and Rural & Close Target Reconnaissance.

 

 

Bernadette O’Brien
BSc (Hons), P Grad Dip. Mfg Tech, MBA

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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.

 

 

David Cazabon
BSc, MSc (Biotech), H.Dip.Pharm.Man.Tech.

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David Cazabon is Senior Consultant with The Compliance Group. After qualifying as a Microbiologist and Biotechnologist, David has spent twenty three years working in the pharmaceutical and medical device industry in Microbiology, Sterility Assurance and Quality Assurance (QP). In his capacity as a Director with Baxter Healthcare, he had responsibility for all aspects of sterility assurance and microbiology including moist heat, gamma, ETO/Gas sterilisation, sterile filtration, contamination control strategy, microbial contamination investigations, microbial/sterility risk assessment, microbiological testing, product transfers, training, and management of regulatory change for all facilities in Europe, Middle East, and Africa.

 

 

Martin Kierans
BSc (Hons), MSc

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Martin Kierans is a senior pharmaceutical professional with over 20 years of experience in Quality Assurance, Quality Control and Quality Systems. Martin has a broad range of international experience across the pharmaceutical supply chain. He has technical expertise and hands-on experience of quality management systems for: in-house and third party manufacturing, packaging and analysis; affiliates and MAH activities including pharmacovigilance, sales & marketing and GDP. Martin earned his Msc degree in Instrumental Analytical Chemistry from Anglia Polytechnic University, Cambridge UK, his BSc (Hons) degree in Analytical Chemistry with Quality Assurance from Cork Regional Technical College and his Postgraduate Diploma in Pharmaceutical Manufacturing Technology from Trinity College Dublin. He is an eligible QP since 2009.

 

 

Ann Ballesty 
BSc (Hons), MBA

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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.

 

 

Andrew Barrett
MPSI, MRPharmS

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After  initially qualifying  in  the  area  of  Quality  Assurance, Andrew  worked in  the  pharmaceutical  industry  in  several Quality roles.  Andrew continued his education to qualify as a pharmacist. His  interest  in  the  Quality  area  has  resulted  in  taking  up  roles  as  a Responsible  person  for  many  companies.  Clients  have  included  small  to  medium  size  business  all  the  way  up  to  Multinationals  looking  for  an  expert  in  the  GDP  area.   More  recentl  Andrew  has  acted  as  a  consultant  in  the  growing   area  of  virtual  wholesaling.  Currently  Andrew  acts  as  Supervising  Pharmacist  in  his  own  Pharmacy business.

 

 

Celine Creighton
BSc.

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Celine Creighton is a Senior Regulatory Consultant with The Compliance Group with expertise in clinical trials and good clinical practice (GCP). Celine accumulated over 9 years experience in all aspects of regulatory affairs with Novo Nordisk, Wellcome and GlaxoWellcome before joining the Irish Medicines Board (IMB), now the Health Products Regulatory Agency (HPRA), in 2002.Being appointed to the position of GCP/Pharmacovigilance Inspection Manager her responsibilities included the conduct of GCP inspections, strategic planning and management of the national GCP inspection programme and development of the pharmacovigilance inspection programme. 

 

 

Mary Wallace
BSc (Hons), MSc

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Mary Wallace has been a Senior Consultant at EUPS since November 2014. She obtained QP status in 1986, and has had over 30 years experience of QP release, QMS and regulatory requirements in the pharmaceutical industry. Her experience has been gained over a wide range of medicinal products including solid dose pharmaceuticals, sterile medicinal products, parenteral nutrition and API production. Mary was instrumental in setting up and establishing the Diploma in Pharmaceutical Manufacturing Technology (QP course) in the School of Pharmacy, TCD. She was the Course Co-ordinator for 10 years. Before leaving TCD in 2000, she introduced and set up the first QP Forum in 1999. Mary has a B.Sc. (Hons) in Chemistry and Maths and an M.Sc. in Phytochemistry from UCD. In the past Mary has worked for Birex Pharmaceuticals, B Braun, LEO Laboratories, Mallinckrodt Medical, Newport Pharmaceuticals, Niche Generics, Pharmafile, Pharmapac, Servier and Warner-Lambert.

 

 

Denise Coakley

BSc., MSc.

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Denise holds a Masters Degree in Industrial Pharmaceutical Science, the qualifications required to work as a Qualified Person (QP). She worked for twelve years in the pharmaceutical and biopharmaceutical industry, internationally, in various departments, including, laboratories, quality, validation, clinical, project management and QP on both start up and operational sites. In 2011 Denise joined the Irish Medicines Board (IMB), now the Health Products Regulatory Authority (HPRA) as a GMP inspector. As GMP inspector she led and performed GMP inspections throughout the world, representing both the HPRA and European Medicines Agency, assessing compliance of manufacturers with EU GMP.  She has experience in the inspection of sterile, non-sterile, biotech and IMP manufacturing facilities as well as contract laboratories, gamma irradiation, ETO and compounding facilities. She was also involved in the training of new inspectors at PIC/S new GMP inspector training and presented at various HPRA information days and QP forums.

Richie O’Sullivan 

MPharm, Msc.

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Richie is a senior regulatory consultant with the compliance group specialising in Good Manufacturing Practice (GMP). He holds an M.Pharm degree, which meets the education requirements to act as a Qualified Person (QP). Richie spent several years working in the pharmaceutical industry as a quality assurance specialist and manufacturing development executive. In addition to these industry roles he also gained practical experience in the development of clinical trial over-labelling and dispensing processes, prior to joining the HPRA as a GMP Inspector in 2016.

Richie worked as a GMP inspector for the HPRA for six years, leading national and international GMP inspections on behalf of the HPRA as well as the European Medicines Agency (EMA). He has experience inspecting facilities that manufactured and/or tested; non-sterile, sterile, human, veterinary and investigational medicinal products. While working as a GMP inspector he also provided technical assessment of variations/new applications for Manufacturing/Importation Authorisations (MIAs) and also provided responses to GMP queries received from the industry.

During his time as a GMP inspector he also represented the HPRA presenting at HPRA and PIC/s GMP Conferences on topics such as cross-contamination control and the management of outsourced activities.