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Tutela Study Day June 2010

MHRA Inspections, Cold Chain and Thermal Mapping

Chairman: Malcom Robinson Worthing & Southlands Hospitals: Blood Transfusion Manager

Malcolm trained as a laboratory scientist in 1976 with the Royal Navy. He became the Navy’s youngest CPO whilst managing the Blood Transfusion laboratory in the Naval Hospital in Plymouth. On leaving the services he jumped “out of the frying pan and into the fire” working in Saudi Arabia around the first Gulf War. After 3 years Malcolm left to work at UAE because they had a grass Rugby pitch! and after breaking his neck he came back to work in the UK as Laboratory and Regional Manager for the Nuffield Hospital in Birmingham. He then became Operations Director of a Private Pathology Company and during this time opened and operated laboratories in the UK, Holland and the Middle East prior to becoming Blood Transfusion Manager at Worthing in 2006. Malcolm is the Chair of the South Thames Transfusion TA(D)G and has experienced 2 MHRA inspections to date.

MHRA Inspections – Cold chain medicines & blood

Ian Holloway – MHRA Manager of the UK Defective Medicines Report Centre

Ian worked for the MHRA inspecting manufacturers and wholesalers both in the UK and overseas as a GMP inspector. This was followed by working as Pharmacovigilance inspector looking at drug safety systems. He now manages the Defect Centre which advises companies on defective products and manages product recall actions. He is a registered pharmacist with an Msc in Pharmacological Biochemistry.


Preparing for inspection

Betty Wickens – NHSBT Quality Systems Audit Manager

Betty has more than 20 years experience in the area of blood transfusion. After state registration as a biomedical scientist Betty was in charge of the Testing Department at Southampton Transfusion Centre, before moving to Quality Assurance. She became Quality Assurance Manager at NHBST in 2004 and led the centre through 5 MHRA inspections. Betty is now the Quality Systems Audit Manager for NHBST, this role involves managing the self inspection and supplier audit programmes, including maintaining a pool of experienced auditors and ensuring maximum value is gained from the self inspection programme. Another Audit Manager role is assisting Hospital Blood Banks with their BSQR compliance via mock inspections and workshops.


Thermal Mapping the process & Record Management

Michelle Evans – Welsh Blood Service

Michelle has worked for the Welsh Blood Service for 23 years. She started as a Junior ‘B’ Medical Laboratory Scientific Officer (MLSO)
and has been working in the QA laboratory since 2002 when she joined as Section Leader. In 2007 Michelle was appointed as the Head of the Laboratory. The QA Lab is the calibration authority for the WBS and undertakes the validation of all storage systems. In addition to this the Lab also performs the quality monitoring of the processing function and bacterial monitoring of platelet components.


Validation & Documentation – Monitoring Methods & Troubleshooting

Wayne Goddard – Laboratory Manager Quality Control West Midlands

I am Laboratory Manager for Quality Control West Midlands which is the Regional Pharmaceutical Quality assurance service for the West Midlands Strategic Health Authority. QCWM provides QA advice to 44 NHS Trusts across 6 counties. I have been with the service since 1992 and have been Lab manager since 2005. I am a serving expert with the British Phamacopoeia Commission (Unlicensed Medicines), I represent QA issues on local, regional and national pharmaceutical procurement groups. I have also served on the National NHS Pharmaceutical QA Committee, the MHRA Liason Group and I am visiting lecturer to the University of Leeds.


Presenter contact details

Sally Towle (Tutela) – stowle@nextcontrols.com

Malcolm Robinson (W&SH) – malcolm.robinson@wsht.nhs.uk

Ian Holloway (MHRA) – ian.holloway@mhra.gsi.gov.uk

Betty Wickens (NHSBT) – betty.wickens@nhsbt.nhs.uk

Michelle Evans (WBS) – michelle.evans8@wales.nhs.uk

Wayne Goddard (QCWM) – wayne.goddard@uhb.nhs.uk

Tim Smith (Sanyo) – tim.smith@sanyo.com

Candidate Comments

“Thank you for a very informative and useful day, I now have a lot more work to try and fit in to make the changes needed! Thanks again.”

Daniel Green Pharmacy QA Stoke Mandeville Hospital

“The day long event was excellent and this was reflected in the number of very attentive delegates present and the number of varied questions asked by the delegates to the different speakers.”

Malcolm Robinson Chair of the event

“Lots was covered and will prompt me into action. There are plenty of issues raised that I will have to address at work. The MHRA requirements bit of the study day was absolutely useful! Fantastic and Fruitful Educational Study day. Thank you and Well Done!”


“Very informative study day , well organised at easy to find venue. Great opportunity to discuss issues with speakers and other colleagues”.

Jane Murphy RBH Reading

“Ideal Day! Just the right amount of information and at the correct level.”


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