Process Validation for Pharmaceuticals and Medical Devices

Oct 22nd, 2012Oct 23rd, 2012
London, H9
GB
http://www.management-forum.co.uk/gxp/eventid/2088
Phone:44 (0) 1483 730071
This seminar will help you understand the link from product requirements to equipment verification and process validation. It will also help you establish a process validation program.
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An example of a typical BgRT plan: A) PET scan on diagnostic PET/CT and B) X1 PET-Linac for patient #15 with a PET avid rib metastasis with GTV size= 3.1 cc, PTV = GTV + 5mm, BTZ (biological tracking zone) = PTV + 5 mm, AC = 14.33 kBq/mL and NTS = 21.04. Red, magenta, and green contours represent GTV, PTV, and BTZ. C) Dose distribution and D) bounded-DVH of a BgRT plan are displayed for the same patient. The bounded Dose-Volume Histogram (DVH) models variations in BgRT delivery, encompassing fluctuation in target background signal variation, target localization and dose delivery uncertainties.
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