FDA Inspection – A survival guide
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Resources
In our Resources section you will find useful information in the form of industry-relevant white papers, downloadible content from our study-days and sponsored events together with useful links.
FDA 21 CFR part 11 compliance
Posted on Friday November 11 2011
Tutela FDA 21 CFR part 11 compliance 09.11.11
Read more...Tutela Study Day Nov 2010
Posted on Tuesday November 08 2011
Tutela Educational Study Day Chairman : Hazel Forde – The Anthony Nolan Trust: Histocompatability Laboratory Manager As the Research Laboratory Manager at The Anthony Nolan Histocompatability Laboratories attached to the Royal Free Hospital Hazel’s work covers two areas 1) Immunotherapy using Cord Blood Stem Cells: looking at complications that can occur post-transplant, e.g. infections. For….
Read more...Tutela Study Day June 2010
Posted on Monday November 07 2011
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….
Read more...Storage & Transportation of Medicinal Products
Posted on Wednesday November 02 2011
RECOMMENDATIONS ON THE CONTROL AND MONITORING OF STORAGE AND TRANSPORTATION TEMPERATURES OF MEDICINAL PRODUCTS By John Taylor, CChem, FRSC Manufacturers’ recommendations concerning storage temperatures should be observed and this may involve the use of specialised storage and transport facilities. Temperature monitoring devices should be used to demonstrate compliance with the designated temperature ranges. Click here….
Read more...Useful Links
Posted on Wednesday November 02 2011
NHS The FDA – U S Food and Drug Administration MHRA – Medicines and Healthcare products Regulatory Agency We’re listed in the UK Open directory – the best search engine friendly directory around Complete Attorney List Directory B2B Directory – Useful directory of….
Read more...Tutela Study Day Mar 2011
Posted on Tuesday October 25 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….
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We have experienced excellent service and support. As we live in a hurricane zone, it...
Kathy Rogers, Jupiter Medical Center FL.
Overall our experience with the Tutela system has been very positive. Installing the Tu...
Michael Vassallo, Southeast Tissue Alliance FL.
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