About Watermark Quality Consultants
Barbara became an independent pharmaceutical consultant specialising in blood and tissues in 2006 following over thirty years experience in the field. Barbara holds a certificate in Quality Assurance Management and is a certified Quality Auditor in addition to holding her professional qualifications as a Medical Scientist. Her in depth knowledge of the subject matter together with her regulatory experience provides the skills necessary for the quality services you require.
Barbara’s career in Blood and Tissues commenced in the UK where she gained a great deal of practical experience from working in both hospital laboratories and the Blood Transfusion Service. This continued following her move to Canada where she developed her skills in Quality Assurance with the national blood service.
Barbara held the position of inspector of Blood Establishments for Health Canada for several years during which time she was also responsible for developing and revising compliance guidance documents for industry with respect to blood and tissues.
Following her return to the UK, Barbara worked with the Medicines and Healthcare products Regulatory Agency (MHRA) contributing to the development of the current legislation for blood and blood components. She was one of the UK government representatives at the European Commission meetings during the preparation of the Directives for Blood and Blood Components and was involved with the transposition of the Directives into UK legislation.
As a Good Manufacturing Practice (GMP) inspector she conducted numerous inspections of Blood Establishments on behalf of the MHRA. Her role as an MHRA inspector also included the inspection of Tissue Banks as part of the Department of Health’s voluntary accreditation scheme for Tissue Banks in the UK. Inspection of pharmaceutical manufacture, storage and distribution including maintenance of the cold chain are also included in her portfolio.
Since 2006 Barbara has:
- advised competent authorities within the EU for the implementation of blood and tissues legislation
- developed inspection and control measures for blood and tissues regulation (including providing specialised training for inspectors)
- inspected Hospital Blood Banks, Blood Establishments, Tissue Establishments
- conducted GMP training for pharmaceutical producers in the UK, Europe and Global institutions
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