Pittsburgh Workshop 2008 - The EMMES Corporation


Pittsburgh Workshop 2008 - The EMMES Corporation

WELCOME!Innovative Cellular Therapies and Methods atGMP Cell Therapy FacilitiesMay 5-6, 52008Introduction & Welcoming RemarksThe EMMES CorporationNational Heart Lungand Blood Institute Slide 1

Workshop Participating CentersUniversity of Pittsburgh Cancer InstituteCAGT - Baylor College of MedicineMCT - University of MinnesotaSlide 2

PACT MISSIONCommitted to the Advancement ofEffective Cellular TherapiesOffer scale-up capability and expertise inthe translational development needed toproduce cell therapy products undercGMP and cGTP regulations for use inclinical trials.Slide 3

PACT MISSION-EDUCATION-Promoting interest in cellular therapyTraining support for investigators to develop knowledgeand experience with regulatory requirementsEducational Web SeminarsOn-site WorkshopsDidactic and interactive training materialsCell therapy facility toursCell Therapy BookSlide 4

Educational Web SeminarsFebruary 2008Cryopreservation of Cell Therapy ProductsOctober 2007Preparing for an FDA InspectionJuly 2007Interpreting AABB & FACT Cellular Therapy Standards-FACTAdverse Event Reporting for 351 ProductsFebruary 2007Adverse Event Reporting in IND StudiesOctober 2006Cell Therapy Data ManagementFacility Master FilesSOP DevelopmentJuly 2006Development & Operation of a QA System for Deviations fromSOPs in a Clinical Cell Therapy LaboratoryJanuary 2006Managing Multiple Specimens in a Cell ProcessingFacilityRapid Release TestingPackaging and Shipping of Human Cell TissueProductsJuly 2005Biological Product Deviation ReportingChemistry, Manufacturing, and Controls Writing forInvestigational New Drug ApplicationsStaff Training & Competency TrainingMarch 2005Facility Cleaning and DisinfectionCell Processing: Validation and PerformanceQualificationEquipment QualificationFor more information visit Slide www.pactgroup5 pactgroup.net

Previous On-site WorkshopsDesign and Operation of GMP Cell Therapy FacilitiesApril 11-12, 2007University of MinnesotaMolecular and Cellular TherapeuticsEarle Browne Continuing Education and Conference CenterDesign and Operation of GMP Cell Therapy FacilitiesApril 4-5, 2006Baylor College of MedicineHouston, TexasFor more information visit www.pactgrouppactgroup.netSlide 6

PACT WEBSITE:www.pactgroup.netSign up for updates on future web seminars and workshopsSlide 7at info@pactgroup.net

WORKSHOP OBJECTIVESTo develop a fundamental understandingof how Good Manufacturing Practice operatesin a cell therapy facilityTo provide a clinical as well as a practicalunderstanding of various innovative cell therapiesTo learn valuable laboratory skills andtechniques through observationSlide 8

CME Accreditation StatementAABB is an approved, accredited provider (Provider number0000381) by the Accreditation Council for Continuing MedicalEducation (ACCME) to provide continuing medical educationfor physicians. AABB designates this education activity for amaximum of 8.5 category 1 credits toward the AMAPhysicians Recognition Award. Each physician should claimonly those credits that he/she actually spent in the activity.Slide 9

CME CreditIf you are interested in obtaining CME creditfor attending this web seminar, please notethat each attendee must:Sign the rosterComplete the surveySlide 10

AABB Live Learning CenterAfter the rosters have been processed, you willreceive an email from AABB with instructionson how to print your CME/CE certificates.Slide 11

Let’s s Get Started!Slide 12

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