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Receive guidance on changing legislation and increasing complexity in the manufacturing and distribution chain
An opportunity to share concerns and learn directly from the MHRA
Learn more about QP and RP responsibilities to make your role easier and save your company money and resources
Opportunity to meet the experts and pose questions to the panel.
The GMP event is ideal for pharmaceutical industry professionals in quality control and quality assurance, regulatory and
compliance involved in manufacturing medicines and is complemented by the GDP event which covers distribution aspects.
The GDP event is suitable for small, medium or large wholesalers and would benefit managers and key staff members involved in
procuring, supplying, exporting, and storing medicines as well as Responsible Persons.
The events will provide latest information and guidance on changing legislation and increasing complexity in the
manufacturing and distribution chain. The symposia will offer a highly interactive ‘hands on’ learning experience; detailed
workshop sessions will review actual sample deficiencies found by regulators and explain how to address and improve
compliance in these critical areas.
Delegates attending the MHRA GMDP symposium will be eligible to claim 5.5 CPD points per day.
Benefits of attending:
gain greater knowledge of the quality issues affecting your organisation
have a clear understanding of your key QP and RP responsibilities and accountabilities with a clear focus on the legal and compliance aspects
gain detailed knowledge on the best in class standards of GDP and GDP and why is it so essential for patient safety
recognise commonly seen GMP/GDP deficiencies and learn how to improve compliance in your organisation
be familiar with new GMP and GDP guidelines as covered by EU directives/regulations and guidelines
have a comprehensive understanding of the MHRA expectations and how to address and correct actual deficiencies
an opportunity to share concerns and learn directly from the MHRA
discover what your peers are doing through managed workshops and network with like-minded professionals
meet the experts: attend break-out sessions with key speakers.
Have you downloaded the MHRA Event App? Get the most out of the event by downloading the App to your smart phone or device. You will be send the relevant event code and log-in details upon registering for the event. The App is available for both Apple and Android, just search MHRA Event App or click on the appropriate link below:
Welcome to the Agenda. You will see a tab for each day on the left. The GDP Symposium is on 6th December and then repeated on 8th December. The GMP Symposium is on 7th December and then repeated on 9th December.
With 3 of London's main tube lines within a 3 minute walk of the hotel, as well as innumerate bus lines, Novotel London West is an ideal base to reach corporate offices or the Capital's main shopping areas.
Located just off the A4 and outside the Central London Congestion ZoneLocated just off the A4 and outside the Central London Congestion Zone, the hotel is just a 20 minute drive from London Heathrow.
Novotel London West offers over 240 on-site car parking spaces (charged at £1.50 per hour for hotel residents) and 5 coach bays, all of which are secure and under cover. For enquiries please call +44(0)208 2377 540.
Novotel London West, Hammersmith (Symposium Venue)
MHRA have appointed Glasgows to organise the event and host the online registration process.
For more information about other MHRA events please visit the conference and education section of the MHRA website: www.mhra.gov.uk.
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Expert GMDP Inspector
I have been with the MHRA since March 2005 as a GMDP Inspector. I have inspected in areas including Sterile Pharmaceutical Manufacturing facilities, non Sterile Pharmaceutical Manufacturing facilities and biotechnology and am responsible for ensuring that the Companies inspected are compliant with EU GMP. I have also taken part in a number of discussion groups.
I have been involved in a number of technological papers including the current version of the PDA Technical Report No.1 and the UK PHSS papers for non-viable monitoring and Bio contamination control strategies. I am currently the Chair person for the joint EMA and PIC/S working group regarding the potential update to EU GMP Annex 1
Prior to joining the Agency I worked in the Pharmaceutical industry for approximately 20 years in positions including Quality Control, Quality Assurance and Production. I
Have a BSc Honours in Microbiology with Genetics, a Post Graduate Diploma in Industrial Pharmaceutical Science and I am also a Member of the Institute of Biology.
Claire joined the agency as a GDP Inspector in January 2013 and has a background in pharmaceutical manufacturing and auditing of 15 years. Aspects of previous roles in a large pharmaceutical company include project management, QMS implementation and Quality Assurance. She is PRINCE2 qualified and has a degree in Business.
Gaynor joined the MHRA as a GDP Inspector in May 2009 formally working in the pharmaceutical wholesale distribution industry for over 10 years as a Project Manager and Business Compliance Manager. Her roles included auditing the organisation to ensure legal compliance with regulatory bodies including compliance to GDP. Gaynor was also involved in a number of large projects including the management of a building project and the implementation of automation in a large distribution site. She has qualifications in Project Management and Health and Safety. Gaynor spent two years as the MHRA's Health and Safety Manager achieving BS18001 certification. She returned to her GDP Inspector role in July 2013 where she is a member of the implementation team for conducting inspections on API distributors and coordinator of the GDP symposium.
Peter is a pharmacist by profession and joined the MHRA in January 2013. Prior to joining the MHRA, Peter had worked in the pharmaceutical industry for over 30 years, focusing mainly on Pharmaceutical Wholesale and Retail Pharmacy.in various managerial roles including Operations Management, Regulatory Affairs, Quality Assurance and acted as Responsible Person for a number of companies in the UK. Peter has experience in the implementation of ISO 9001 and ISO 13485 Quality Systems and is an ISO Pharmaceutical Lead Auditor. He was an industry representative on the BAPW RP Committee, was instrumental in identifying some of the more recent examples of falsified medicines and is a member of the MHRA Falsified Medical Product Stakeholders Group.
GDP Operations Manager
Phil joined the MHRA in the Pharmacovigilance Inspectorate in July 2009. In 2010 he moved to the GDP Inspectorate, where he became a GDP Operations Manager in 2013. He is a pharmacist by profession, who initially worked in the pharmaceutical industry for over 30 years, for 4 different global pharmaceutical companies. His positions included different managerial and project leader roles at all stages of pharmaceutical development. Phil currently manages one of the GDP Inspectorates two operational teams.
Terry is an Inspector within the GDP Inspectorate at the Medicines and Healthcare products Regulatory Agency (MHRA). He joined the Agency in 2009 having previously worked over 25 years in a variety of pharmaceutical industry technical and managerial roles within R&D and QA.
Senior GDP Inspector
A founder member of the GDP Inspectorate when it was created in 2001, he is a Senior GDP Inspector responsible for inspecting the full range of UK distribution companies. He is a member of the PIC/S GDP working group, working on the training and aligning of GDP standards for PIC/S member countries. He was part of the EMA GDP drafting group preparing the GDP Guidelines and updates to the compilation of community procedures and involved in training the GMDP inspectors on the new guidelines. He was also a member of the team who reviewed the UK supply chain and looked at ways to improve the standard of the Wholesale Dealer 'Responsible Person'. He is currently a member of the implementation team for the Falsified Medicines Directive and working on developing the new Risk Based Inspection IT system for the MHRA. Tony has been with the MHRA for 24 years, working initially with the MHRA Enforcement Group where he was a Senior Investigation Officer. As such he was responsible for investigating counterfeit medicines, internet sales and other illegal activity with pharmaceuticals.
Senior GDP Inspector
Madeleine is a senior GDP inspector and joined the MHRA in August 2009. Her previous experience includes NHS pharmacy manufacturing, project management in NHS Blood and Transplant and some teaching within the NHS. Recent projects include working with Cogent to develop the RP Gold Standard and working with the Maritime and Coastguard Agency to improve compliance within the marine sector. Madeleine enjoys contributing to inspector development and inspection consistency. Madeleine is registered with the General Pharmaceutical Council.
Vivian joined the MHRA as a GMP Inspector in 2009. She inspects both sterile and non-sterile manufacturing operations. Her other inspection areas include Good Distribution Practice and importation activities, IMP and QC contract laboratories. She is also a member of the Blood Inspection Team.
Prior to joining the MHRA, Vivian had worked in the pharmaceutical industry for over 15 years in variety of roles including Quality Control, Manufacturing Operations, Quality Assurance and Supplier Management.
Andrew J Gray BSc PhD
Unit Manager Inspectorate Operations
Andrew joined the MHRA in January 2003 as a GLP inspector. In 2004 Andrew was appointed Operations Manager for the Good Laboratory Practise and Good Distribution Practise Groups, taking responsibility for the management of a team of ten inspectors. In May 2006 Andrew took on the role of Heads of the United Kingdom Good Laboratory Monitoring Authority. In this capacity he holds the chair of the OECD GLP Working Group and is a member of the EC GLP Working Group.
Andrew has contributed to a number of national and international guidance documents including the first comprehensive European guidance for laboratories that perform the analysis of samples collected as part of clinical trials. In 2014 Andrew was appointed to the role of Unit Manager Inspectorate Operations with responsibility for the GLP, GCP and GDP inspection teams.
Prior to joining the MHRA, Andrew worked in academia for a number of years performing research on the underlying causes of cardiovascular disease before moving into the pharmaceutical sector where he was involved in pre-clinical drug development.
Jacqueline joined the GDP Inspectorate in 2011. Jacqueline has a degree in Pharmacology with previous experience of working at the Toxicology Unit at Imperial College of Science and Medicine, London. Jacqueline also previously worked in the MHRA Licensing Division as a Scientific Assessor.
Operations Manager, GDP Inspectorate
Peter joined the MHRA in 1993, having spent the previous three years with the Department of Health and NHS Management Executive in Leeds. Peter initially worked in the Enforcement Group and was responsible for conducting a two-year project into the use of Traditional Chinese Medicines in the UK before managing the unit's criminal prosecution team. Peter joined the GDP Inspectorate in June 2002 and became an Operations Manager in November 2011. Peter currently manages one of the GDP Inspectorates two operational teams.
Senior GDP Inspector
Cheryl joined the MHRA as a GDP inspector in 2005. Cheryl is a Chartered Chemist and spent many years working within industry as a research chemist during which time she filed a number of patents both European and Worldwide. She has extensive experience working within Project and Programme Management roles with responsibility for a wide range of projects spanning various scientific and engineering disciplines. As well a performing a full range of GDP inspections nationwide, Cheryl was the MHRA representative on the GDP drafting Group at the EMA. Since the current guidance has been implemented, Cheryl has been leading the project to raise awareness within the medicines supply chain that companies and sites not previously regulated are impacted by the change in legislation.
Unit Manager Inspectorate Operations GMP / GPvP
Richard joined the MHRA as a GMP Inspector in 2001 and is currently a Unit Manager with responsibility for the GMP and GPvP Inspection teams. Prior to joining the MHRA Richard worked in the pharmaceutical industry for over 17 years focusing mainly on the manufacture of bulk active pharmaceutical ingredients. He has experience of process development and technical support and has held managerial positions in both QA and production. Whilst at the MHRA, in addition to the inspection of a wide range of pharmaceutical manufacturers, Richard has been an Operations Manager with responsibility for teams of both GMP and GDP Inspectors and has most recently been part of the Agency team responsible for implementing the changes arising from the Falsified Medicines Directive.
Group Manager, Inspectorate
Mark joined the MHRA in 2002 and is currently the Group Manager for the Inspectorate which comprises of over 80 Inspectors. Mark is a chemistry graduate with an MSc in pharmaceutical sciences. He previously worked in the pharmaceutical industry for over 10 years in a variety of roles including process technology, new product introduction and quality assurance and he is eligible to be named as a Qualified Person under Directive 2001/83/EC.
Expert GMDP Inspector
David has been a GMDP inspector with the UK Medicines and Healthcare Products Regulatory Agency since 2004 with responsibility for leading inspections of pharmaceutical manufacturers and blood establishments in the UK and internationally. In his current role, David is the MHRA representative at the EMA Inspectors Working Group, and other EU and international groups to develop and revise GMP regulations and standards. David leads the agency team responsible for delivering data integrity inspection strategy and training, and is co-chair of the PIC/S data integrity working group. Prior to joining the MHRA, he was a Principal Pharmacist and production manager in the UK’s National Health Service, responsible for the manufacture of aseptically prepared radioactive diagnostic agents, chemotherapy and parenteral nutrition products.
Ewan joined the MHRA as a GMP inspector in January 2013. Prior to joining the Agency he worked in the Pharmaceutical industry for approximately 19 years in positions which included R&D, Scale-up, Process Validation, Outsourcing, Regulatory Affairs and Quality Assurance.
George joined the MHRA in April 2016 as a GMDP Inspector. George has a degree in pharmacy and prior to joining the inspectorate, he worked in the National Health Service in both Production and QA roles. This included aseptic manufacture, radiopharmaceuticals, non-sterile and sterile small-scale hospital manufacturing. He has also worked previously in the MHRA in the Licencing Division, involved in assessing initial generic marketing authorisation applications and variations.
Graham Carroll has been a GMDP Inspector with the MHRA since 2013, and is a Mechanical Engineer (MEng) by training. Prior to joining the MHRA Graham spent eight years working in the pharmaceutical Industry in the areas of human plasma fractionation and sterile product manufacturing; this included operational and managerial roles in Validation and Quality Assurance. As a GMDP Inspector, Graham specialises in the inspection of sterile product manufacture as well as the collection, processing and supply of blood and blood components.
Alan joined the MHRA in July 2013 as a GMDP Inspector. He is an Applied Biological Sciences graduate and has inspected in areas including sterile manufacturing, non-sterile manufacturing and investigational medicinal products. Prior to joining the Inspectorate, he worked in the pharmaceutical industry for approximately 20 years in various roles including Quality Control, Quality Assurance and Production.
Bernadette is a GDP Inspector and joined the MHRA in March 2005. Her previous experience includes local government enforcement duties within a Trading Standards environment. Bernadette spent 10 years working as an Investigator within the MHRA Enforcement and Intelligence division dealing with criminal investigations. She has played an important role in the year on year success of the MHRA's Operation Pangea which focuses on the illegal internet trade of medicines and medical devices globally. In 2015, £15.8 million worth of fake medicines and devices were seized during UK operations. Bernadette is an accredited Counter Fraud Specialist.
Naseem has been with the MHRA since 2006 and is an Intelligence Analyst in the Enforcement Groups Intelligence Unit. In 2006 Naseem completed the Covert Internet Investigators course run by the National Centre for Policing Excellence. He is currently the Enforcement Group’s Covert Internet Investigator and responsible for the conduct of internet investigations and covert internet test purchases. Naseem has also completed the Initial Analytical Techniques Course run by the National Policing Improvement Agency. Before Joining the MHRA in 2005, he completed an LLB (Hons) and MA in Intelligence & International Security.
Bio Available Soon
Sandra Bax (DMRC)
Sandra joined the MHRA as Manager of the DMRC in 2015. She is a Chartered Chemist and a Qualified Person, and has over thirty years experience in the pharmaceutical industry. She has worked in large multi-nationals, as well as medium and small start up companies. As a QP, Sandra has expertise in GMP and pharmaceutical quality systems. Through her earlier roles in R&D Analytical Development she gained knowledge of stability testing of formulated products and active substances, and in New Product Introduction was involved in cleaning validation and technology transfer.