Experienced and Independent
Piera Lukes - Managing Director
Piera founded IT’sQA in 2001. She has over 13 years’ industry experience in clinical Quality Assurance and started her career as a Clinical QA Auditor within the CRO environment. She joined a specialist QA auditing company to broaden her experience in international auditing to GCP standards. Piera gained a doctoral degree in Italy and obtained a PhD in the UK. She has a risk assessment qualification and a diploma in Research Quality Assurance. In BARQA, Piera has been the regional coordinator for the Anglia Region and was a member of the Membership Working Party in 2004. She is fluent in Italian.
Throughout her 13 years’ experience she has worked with pharmaceutical, CRO and IT industries conducting GCP audits and specialising in IT and statistical auditing. Recently she has been involved in providing training, preparing and facilitating regulatory inspection and setting up and managing QA and SOP systems. Her involvement in a wide range of quality management projects enable her to handle the strategic aspects of QA programmes as well as effectively manage and implement more challenging projects.
Anna Peplinska - Quality Manager
Anna joined IT’sQA as a Senior Consultant in 2003 with over 20 years' experience within clinical and pre-clinical QA. After completing an MSc, she became a toxicologist working to GLP in a preclinical contract laboratory before progressed into Quality Assurance where she developed her auditing skills. Subsequently she moved into clinical Quality Assurance to further her auditing skills. She then joined Shire Pharmaceuticals to set up the QA function within the R&D group with responsibility for both clinical and preclinical programmes. A fellow member of BARQA, Anna has been an active member of the Meetings Committee and a Board Member. She is fluent in Polish.
Anna’s experience includes conducting preclinical and clinical audits and preparing and facilitating regulatory inspections. She specialises in qualification audits as well as setting up and managing QA and SOP systems. Over the years she has trained and mentored auditors and continues to do so.
Harold Neal – Senior Consultant (GCP)
Harold joined IT’sQA as a Senior Consultant in 2004 and has over 25 years' experience in Quality Assurance. Harold has worked in a number of large pharmaceutical companies and CROs. He started his career in quality assurance as a GLP auditor before setting up a GCP QA function. He has conducted a variety of GCP, GLP and GMP audits in all areas of clinical development, throughout Europe, (including Eastern Europe and Russia), Asia, United States, Canada and Australia. He has also carried out assessments of companies prior to MHRA mandatory inspections. Harold has a BSc (Hons) in Agricultural Zoology and a PhD in Electrophysiology. He is a fellow member of BARQA has a basic knowledge of French.
Harold is well acquainted with all aspects of GCP requirements including ICH, EU and FDA standards. He has gained expertise in the conduct of routine and for-cause audits on all phases of clinical research as well as assessments of laboratories and CROs.
Karen Hearn – Senior Consultant (GCP)
Karen joined IT’sQA as a Senior Consultant in 2007. She has over 15 years' experience in Quality Assurance. After graduating and completing a research position, Karen joined Allergan Optical with responsibility for the overall co-ordination of clinical research activities in the UK. She then moved to Ipsen where she continued within clinical research subsequently heading up the UK QA department. She has a BSc (Hons) in Biology, is a member of BARQA and speaks basic French.
Karen’s experience includes auditing to GCP, preparing investigational sites and sponsors for regulatory inspections from European and US agencies, auditing Phase I studies, Clinical Laboratories and Contract Research Organisations. Karen’s experience also includes conducting document and system audits, computer system validation audits, the development and maintenance of SOP systems, preparing and reviewing SOPs, and setting up procedures, systems and training programmes within the QA department and across the company.
Carolyn Mann – Senior Consultant (GCP/Pharmacovigilance)
Carolyn has over 30 years' experience in the pharmaceutical industry. She started out in 1977 when she worked within the laboratory and then clinical research before moving into quality assurance. She has 20 years' experience in GCP Quality Assurance and over 10 years' in GPhVP Quality Assurance. Carolyn is a member of BARQA and has served on both the Due Diligence and Medical Devices Working Parties.
Having conducted around 400 audits and supervised many more in a number of European countries in the therapeutic areas of dermatology, respiratory, pain & inflammation and cardiology, she has further developed her expertise in GCP and GPhVP QA. She experienced a first European GCP inspection in 1995 and has subsequently had experience of numerous GCP and GPhVP inspections.
Anders Nyberg – Senior Consultant (GCP)
Anders is based in Europe and has nearly 30 years' experience within the pharmaceutical industry. Anders gained his audit experience in Lundbeck and later in Ferring. Before joining Lundbeck in 2002 he worked at different positions in the pharmaceutical and CRO industry in Sweden, in both domestic and marketing companies. He has a BSc in Chemistry and Biology, is a member of Royal Swedish Pharmaceutical Society, where he is a Speaker, and actively participates in networks and workshops in GCP. Apart from Swedish, Anders has a good knowledge of, and speaks, Danish, Norwegian, English and German.
Anders has developed expertise in conducting audits of sites, clinical trial reports, clinical study protocols, CRFs, pharmacovigilance, vendors, subsidiaries, and other activities related to clinical trials. His broad experience includes conducting audits according to specific plans, providing advice, and preparation for and participation in regulatory inspections.
Shankar Seetharaman – Senior Consultant (GMP)
Shankar is a Qualified Person for Investigational Medicinal Products with over 20 years' experience in the pharmaceutical and biotechnology industries and NHS trusts. Shankar first joined the pharmaceutical industry as a QC Microbiologist with Celltech Biologics. After an excellent grounding here he moved to Cantab to set up a QA and QC department for a GMP pilot plant. He held positions in pharmaceutical and biotechnology companies managing and conducting GMP audits before joining Guy’s and St Thomas’ Hospital in 2002 as Director of Quality where he carried out the role of “Qualified Person”. Shankar completed a post graduate diploma in Industrial Pharmaceutical Studies, is a lecturer in MSc course in Quality Management Systems at Anglia Polytechnic University and a visiting lecturer in MSc course in Pharmaceutical Analysis and QA at Kings College, London. He is a member of BARQA.
Over the years he has gained extensive experience across a wide range of therapeutic areas and has conducted audits in all GxP disciplines and in all areas of pharmaceutical development. He is now focussed on GMP audits and training as well as providing QP services.
Bob McDowall – Senior Consultant (GxP)
Bob is a bioanalytical chemist who has 6 years' experience in forensic toxicology with a PhD and 15 years working as a bioanalyst in clinical and preclinical development in two major international pharmaceutical companies This saw him being responsible for study design, acting as a study volunteer and bioanalysis of study samples including management of CROs. Bob has worked for the past 17 years as a consultant in GLP, GMP and GCP. His expertise in consultancy is in process mapping and redesign, management consultancy (as an adviser to PricewaterhouseCoopers and Cap Gemini), computerised system validation and computerised system specification, selection and implementation. Bob has a basic knowledge of German and French.
Bob has been a trained United Kingdom Accreditation Service (UKAS) auditor since 1994 and in this capacity has conducted audits for healthcare companies and related industries. He has conducted GCP audits of central clinical laboratories, computer data centres, process audits of clinical data management and human pharmacology departments as well as dossier submission companies. He has also conducted vendor audits of software companies for clients. Bob also presents several regulatory compliance training workshops including one for auditing computerised systems for GxP compliance.
Chris Montgomery - Senior Consultant (GxP)
Chris joined IT’sQA as a Senior Consultant in 2009 with over 20 years' experience across the GxPs and 11 years in clinical QA focussed on IT audit and compliance.
Chris was a BARQA board member and chaired the Computing Committee from 2006-2009. He is Course Principal for both the Validation and Auditing of Computerised Systems courses.
Chris began his career in the pharmaceutical industry with Beecham Research and Development divisions which led to an early interest in programming when computer programmes were often user-developed. This experience ultimately resulted in the addition of a PGDip in Computing to his BSc in Biology. Career moves took him to British Biotech research, then into manufacturing where he cut his GMP teeth. The next role was in Clinical QA where Chris picked up auditing skills looking at compliance with the BS/ISO 17799 Information Security Management standard. This led subsequently to a role in computerised system compliance at Celltech and exposure to GLP. Further experience was gained at UCB in Belgium and also at Shire Pharmaceutials.
Shenaz Vakharia - Senior Consultant (GCP)
Shehnaz is based in India (Mumbai) and has nearly 12 years' experience in the pharmaceutical industry. She started in 1997 as a Clinical Research Associate (CRA) with Pfizer and then worked as a Data Manager for three years prior to joining the Medical Division in Pfizer as Head, Quality Standards.
She is an ISO trained auditor and her experience includes conducting investigator site audits in India and Africa for Phase II & III studies for Investigational Products as well as Biological, GLP audits in India and UK, CRO audits in India and Taiwan and Data Management & Medical and Regulatory Affairs Systems’ audits for CROs and Pharmaceutical companies in India.
She is a member of BARQA and has served on the Due Diligence working party. She is also a member of the Society of Quality Assurance (SQA), American Society for Quality (ASQ) and Drug Information Association (DIA). Recently she has also been involved in providing training and has conducted sessions at Annual DIA Meetings, in Boston (June 2008) and San Diego (June 2009). She is on the core committee and faculty at the ‘Diploma in Clinical Research’ conducted by St. Xavier’s College, Mumbai.
Tristan Brittain-Dissont – Business Development Director
Tristan has long-standing experience in the contract service arena, beginning with Covance in the late 1990s. Since that time he has worked extensively in growing businesses such as Intercern, a niche CRO; Progenix Research, a toxicology facility; and Alpha Biologics, a cGMP contract manufacturer.
Zeenat Munglee - Office Manager
Zeenat joined IT’sQA in 2007 as documentation associate having previously worked in administration and as Product Engineer managing and writing IT technical documentation. Zeenat was promoted to office manager in 2008 and occupies a key role in supporting the operations of the company. Zeenat has a BSc (Hons) in Computing and speaks French and Urdu.