Madeleine has worked in the pharmaceutical sector throughout her career, spanning NHS manufacturing, NHS Blood & Transplant and, until recently, as a senior GDP inspector with the UK regulator, MHRA.

Madeleine’ s special focus has been on training and development of the Responsible Person; risk and company culture; development of the QMS; and niche pharmaceutical supply chain sectors such as the marine industry, MA holders and transport. In 2019 Madeleine moved into compliance-focused training and consultancy to continue to meet GxP regulatory requirements and challenges and to provide clarity and guidance to manufacturers and wholesalers.

Experienced Consultant and former MHRA senior GDP inspector with a demonstrated history of working in the pharmaceuticals industry. Skilled in Pharmaceutics, Good Distribution Practice (GDP), Quality Management Systems, Regulatory Requirements, and Healthcare. Strong consulting professional with a Master of Business Administration (MBA) focused on Project Management from University of Wales, Cardiff. Experienced teacher/trainer with PGCE providing Cogent accredited GDP courses through SeerPharma (UK) and continuing education courses in GDP and associated areas.

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Shahbaz Sarwar joined SeerPharma in 2019. As a former MHRA Inspector Shahbaz is able to offer first hand insight into the understanding and application of the regulatory guidelines and regulations to any business.

Shahbaz’s special focus has been to help provide practical advice for compliance against GDP guidelines and Regulations. Shahbaz is a Contract RP and his favourite topics include audits, quality management systems, falsified medicines and complex supply chains.

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Debra has been our Business Support Manager for the past 21 years. She ensures the smooth running of the administration side of the business to allow the Directors to concentrate on developing the business.

Debra works with the SeerPharma UK management team to set up training sessions. Much of her role involves organisational planning and liaising with the Directors, associate trainers, delegates and suppliers to ensure all the logistics are in place. She is also actively involved in the client invoicing, email management, database administration and marketing for the business.

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Mariam is a Pharmacist by profession, having experience in the UK community pharmacy sector since 2009. Her experience spanned the pharmaceutical field, where Mariam set up a wholesale distribution company. As a WDA(H) holder, the company specialised in the export of medicinal products, medical devices, and vitamins & supplements to the Middle East. As an expert Responsible Person, the high level of compliance and excellent performance demonstrated during regulatory audits did not go unnoticed and Mariam soon took on the role of GDP Inspector for the MHRA.

More recently, Mariam joined the SeerPharma (UK) team as an associate in order to aid pharmaceutical companies in their compliance with GDP and the UK Human Medicines Regulations 2012. Mariam is an experienced trainer and provides specialist training on the Responsible Person “Gold Standard” course which is accredited and certified by Cogent and recognised by the MHRA. She helps to ensure Responsible Persons and organisations develop a suitable Quality Management System (QMS) and maintain the highest competency in GDP and maximise their performance.

Mariam still works as a Pharmacist, to continue to appreciate all parts of the medicines supply chain, which gives her a unique perspective as an expert GDP Pharmaceutical Consultant. She also works as an aesthetics practitioner, providing cosmetic enhancement services to private clients. This gives her a particular insight into the compliance needs of the aesthetics sector.

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Gaynor is a former MHRA Senior Good Distribution Practice (GDP) Inspector with over 24 years of experience, spanning the pharmaceutical wholesale sector and the UK medicines regulator.

While working in industry, Gaynor project managed the implementation of an automated ‘A’ Frame system, WHMS, warehouse build and audited to ensure GDP compliance.

Using her extensive knowledge of GDP, Regulatory Requirement, Quality Systems and Quality Risk Management, Gaynor worked extensively in the training and mentoring of MHRA GDP Inspectors.

Having worked both within the UK medicines regulator and in industry as a Project and Business Compliance Manager, Gaynor understands the pressures and complexities on WDA(H) & WDA(V) holders and the necessity to fulfil their legal obligation and comply with the regulatory requirements in protecting public health.

As part of the SeerPharma UK team, Gaynor has the experience, knowledge and understanding to make the journey to compliance and the protection of public health a more simplified and streamlined process for both RPs and Licence Holders.

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Arvind brings 23+ years of experience in the pharmaceutical industry to his consultancy role. He has been a Qualified Person (QP) by UK permanent provisions since 2011, and is also a Chartered Chemist, Chartered Scientist, Industrial Pharmacist and Responsible Person / Responsible Person (Import).

Arvind has quality governance and leadership experience gained in multiple levels of organisation (small, medium, large, and multinational) within various types (manufacturing facilities, distribution sites, virtual, third party management and matrix organisations) and in different cultures. Arvind’s GMDP experience covers manufacturing, process validation and formulation development of tablets, capsules, and MDI inhalers. Proven ability and exposure in manufacturing and quality assurance as a QP, working across product lines such as tablets, capsules, MDI inhalers, ointments, creams, gels, liquid sprays, aerosols, and nasal sprays. Hands on experience in sterile dosage forms, Drug-device combination products and Biosimilars.

Arvind also has experience in quality noncompliance remediation projects, Quality metrics deployment, Inspection readiness, CMC quality expert statements and clinical trial protocol review for investigational medicinal products.

Arvind has extensive GxP auditing and inspection experience acting as lead auditor for audit/inspection programme for the:

• Good Manufacturing Practice (GMP) facility and systems (including automation systems)
• Good Distribution Practice (GDP) audits for the supply chain and distributions sites
• Good Clinical Practice for Clinical Trials (GCP)
• Good Pharmcovigilance Practice (GPvP) internal audits and service providers.

In 2017, Arvind became an independent consultant and routinely prepares and delivers training programs on the topics related to QP study guide modules and problem-solving scenarios, OOS Investigation, Statistical process control and sampling, QRM tools and Root Cause Analysis techniques, Legislation Impact assessments and quality evaluation/Gap analysis.

Arvind has an MSc degree in Experimental Therapeutics from University of Oxford, MSc degree in Industrial Pharmaceutical Sciences from Royal Colleges of Surgeons Ireland, and a Bachelor’s degree in Pharmacy from Madurai Medical College, India.

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Bob has worked in the Pharmaceutical Industry for forty years. His experience includes Production and Engineering Management, New Product Development, Factory Design, Supply Chain Management, Validation and a variety of support functions. He has a special interest and expertise in the use of pharmaceutical risk management and modern quality methodologies in the various aspects of regulatory compliance and GMP.

As well as his experience in the Pharmaceutical industry, Bob has also worked in a range of other industries, including: aerospace, precision engineering, FMCG, insurance and e-commerce. This breadth of experience presents the opportunity for Bob to introduce new ideas and best practices when working with his current pharmaceutical clients.

Bob is Vice-Chair of the Pharmaceuticals Technical Activities Committee of the Institution of Mechanical Engineers.

Bob is a Chartered Engineer, a Fellow of the Institution of Mechanical Engineers and a Fellow of the Institution of Engineering and Technology. He is also registered with FEANI (Brussels).

Before stepping back into a less active role, Bob ran the UK arm of SeerPharma for twenty years. Bob now brings his expertise to pharmaceutical consultancy projects and pharmaceutical training courses.

Robert J Hayes BSc CEng FIMechE FIET

Steve is a former MHRA Senior GDP Inspector. During his 16 years at the MHRA he conducted GDP inspections of companies covering a wide range of size and complexity across the UK pharmaceutical supply chain. This included large multinationals, full-line and short-line wholesalers and niche suppliers of medicinal products.

This range of experience led Steve to become involved in the editing and publishing of several issues of the MHRA Rules and Guidance for Pharmaceutical Distributors (Green Guide). Steve has contributed to various external publications. Steve’s was particularly interested in fostering the right attitude amongst WDA(H) licence holders and those acting as Responsible Person (RP). His popular blogs, covering cold chain and other areas, can be found on the MHRA gov.uk website.

Steve contributed as a member of the PIC/S GDP Working Group since 2008 and latterly as Chairperson before he retired, overseeing worldwide collaboration in the GDP and pharmaceutical supply chain. This contributed significantly to an improvement in the integrity of the global pharmaceutical supply chain.

Steve now contributes to the Cogent Gold Standard training for the Responsible Person ensuring his memorable style, invaluable experience and expertise enhance the learning of new and experienced RPs.

Christine worked as an Inspector for the Veterinary Medicines Directorate (VMD) for over eleven years including four years as Head of the Inspection Team. She has conducted approval and routine inspections and investigations of animal health retailers, veterinary practices, wholesale suppliers, commercial and on-farm manufacturers, and distributors of feedingstuffs containing veterinary medicinal products and specified feed additives.

This involved working closely with other Regulators such as MHRA, GPhC, RCVS for combined inspections.

Christine has always had a strong interest in pharmaceutical compliance education and training, and has provided many in-house and public presentations and training throughout UK and on feed production and compliance in Ethiopia (2018)

Previously Christine has also worked in Contingency Planning and Emergency Preparedness and has prepared and participated in Government Exercises and two Animal Disease outbreaks. She also has twenty years’ experience in animal feedingstuffs manufacture in relation to quality control, HACCP, Site Quality Management and ruminant nutrition. Trained to IRCA ISO 9001:2015 standards, Christine carried out approximately 1500 inspections / audits during that time.

Christine successfully completed the Cogent Gold Standard Responsible Person (RP) course, and now is a consultant providing advice and training in relation to pharmaceutical GDP, wholesale and retail regulation, specialising in veterinary medicines. She has a particular interest in the challenges presented to WDA(H) wholesalers as they strive to achieve compliance in the handling of both veterinary and human medicines. Christine also brings her expertise to her role as a contract WQP (Wholesale Qualified Person) on a WDA(V).

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Alan is a highly experienced and respected professional in the pharmaceutical industry, last serving as a Lead Senior GDP (Good Distribution Practice) Inspector at the Medicines and Healthcare products Regulatory Agency (MHRA). With over 30 years of experience in industry and working for the MHRA, he has developed a strong reputation as a skilled and knowledgeable expert in quality assurance, regulatory compliance, and supply chain management.

Alan began his career in the pharmaceutical industry in the early 1990s working in a range of roles from pre-clinical research to full scale manufacture, focusing on quality and compliance. He quickly developed a passion for ensuring that medicines were safe and effective, and worked diligently to build his expertise in regulatory compliance and good practice.

As Lead Senior GDP Inspector at the MHRA, he played a critical role in protecting public health by ensuring that pharmaceutical products are distributed safely and securely. He was responsible for developing policy & practice and guiding a team of inspectors who carry out inspections of wholesalers and distributors to ensure that they are complying with the regulations governing the distribution of medicines. Alan is highly respected in the industry for his deep knowledge, his commitment to quality, and his unwavering dedication to protecting public health. He is widely regarded in his field and continues to be a sought-after speaker and commentator on issues related to pharmaceutical compliance.

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