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Tutela Study Day Mar 2011

CPA Inspections – An Inspectors View

Gwen Guthrie – CPA: Regional Assessments Manager

Gwen started out with the CPA in 1992 as a Peer Assessor for Haematology and since 2006 has been a Regional Assessment Manager. Previously to working with the CPA Gwen’s background was within NHS working predominantly in Haematology and Immunology. She is a ‘Fellow of the Institute of Biomedical Sciences’ and spends much of her time lecturing at various conference around the country. Gwen will be presenting on “CPA Inspections, an Inspectors view.” With comments added from Ian Holloway from the MHRA. Gwen’s message will be on the similarities between the two perspectives and the take home messages from both points of view.


MHRA Inspection/Re-inspection how to prepare.

Julie Ryan – Pathology Quality Manager at the County Durham and Darlington NHS Foundation Trust.

Julie will present on “How to Prepare for an MHRA Inspection and a re-inspection.” Julie has been in the NHS for 17 years and a Quality
Manager within County Durham & Darlington Trust for the last 5 years. She supports Pathology, Fertility Services and Theatres through the inspection and re-inspection process by CPA-UK, Human Tissue Authority, HFEA, MHRA and any other quality related inspections. This involves supporting completion of applications, preparation before inspection, support during inspection, feedback and corrective actions after the inspection and support of preventative actions for future inspections. Julie has been through numerous inspections and re-inspection with all of the accreditation/ licensing bodies and hope to share a little of what we learned from this process as we now find these a very positive experience. In her spare time she enjoy participating in archery competitions all around the country which is great for meeting new people and stress relief and is currently ranked 37th Lady Compound Archer in the UK.


Validation & Documentation Monitoring Methods & Troubleshooting

Wayne Goddard – Laboratory Manager Quality Control West Midlands

Former manager in NHS Regional QA Service. With 20 Yrs experience in the field, including publishing of National, Regional & local standards. Serving expert with British Pharmacopoeia Commission and visiting lecturer to the University of Leeds. Wayne will cover Validation, Terminology and how to validate successfully, documentation, monitoring methods and trouble-shooting. Wayne will be presenting on “Monitoring Methods and troubleshooting.”



Temperature mapping – How to perform and document

Angela Green – Maidstone General Hospital Transfusion Practitioner

Now the Transfusion Practitioner at Maidstone General Hospital Angela has been in her current role for 6 years. Angela started out in 1990 as a trainee Biomedical Scientist in Maidstone before moving to The William Harvey in Kent and then to Taunton in the West Country. After witnessing first hand what can go wrong in blood transfusion Angela took an opportunity to move back to Maidstone to become the Trust Transfusion Practitioner that she is now. Her role includes Temperature Monitoring and Cold Chain Management as well as her normal biomedical science duties. Angela will be presenting on “Temperature Mapping and Validation – how to perform and document.”


Presenter contact details

Sally Towle (Tutela) stowle@nextcontrols.com

Michael Edwards (Tutela) medwards@nextcontrols.com

Gwen Guthrie (CPA) gwen.guthrie@cpa-uk.co.uk

Angela Green (MGH) a.green@nhs.net

Wayne Goddard (QCWM) wgoddard@btinternet.com

Julie Ryan (CDDFT) julie.ryan@cddft.nhs

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