{"title":"Good Clinical Practice for the Laboratory Scientist","description":"\u003cp\u003e\u003cimg title=\"Course Description\" border=\"0\" alt=\"Course Description\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseDescription.jpg?n=8101\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eThis course is designed particularly for the laboratory scientist to provide an appreciation of the regulated environment in which clinical studies are conducted and its relevance when collecting and analyzing biological specimens during a study. The drug development process (discovery through post-market) will be reviewed with particular attention to the fundamentals of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and where\/how they apply. Examples and the impact of non-compliance will be discussed. Review and reinforcement of important concepts, such as laboratory accreditation, will be achieved through discussion and examples. The role of quality management in GCP Laboratories will be evaluated along with the standards to have in place that will ensure compliance, including outsourcing clinical laboratory activities. The challenges when conducting global studies related to specimen collection will also be discussed.\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Learning Objectives\" border=\"0\" alt=\"Learning Objectives\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/LearningObjectives.jpg?n=1786\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eReview the drug development process from discovery through post-market\u003c\/li\u003e\n\u003cli\u003eDescribe the regulated environment in which clinical studies are conducted, including the handling\/analyzing of biological specimens\u003c\/li\u003e\n\u003cli\u003eDiscuss the fundamentals of GLP, GCP and GMP and where\/how they apply\u003c\/li\u003e\n\u003cli\u003eExamine examples and impact of non-compliance with GLP\/GCP\u003c\/li\u003e\n\u003cli\u003eDescribe the role of quality management in GCP laboratories and the standards to have in place that will ensure compliance\u003c\/li\u003e\n\u003cli\u003eDiscuss outsourcing clinical laboratory activities to minimize compliance risks\u003c\/li\u003e\n\u003cli\u003eIdentify the role of laboratory accreditation in clinical studies\u003c\/li\u003e\n\u003cli\u003eDiscuss the additional challenges related to specimen collection when conducting global studies\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Who Should Attend\" border=\"0\" alt=\"Who Should Attend\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/WhoShouldAttend.jpg?n=5464\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eLaboratory scientists\u003c\/li\u003e\n\u003cli\u003eResearch assistants\u003c\/li\u003e\n\u003cli\u003eLaboratory supervisors\u003c\/li\u003e\n\u003cli\u003ePrincipal scientists\u003c\/li\u003e\n\u003cli\u003eResearch personnel that write protocols and\/or handle\/analyze biological specimens collected during a clinical study (analysis for drug metabolites, biomarkers, investigational products)\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Instructor\" border=\"0\" alt=\"Instructor\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/Instructor.jpg?n=4140\"\u003e\u003c\/p\u003e\n\u003cp\u003eGary B. Freeman, M.S., C.C.R.A.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for complete trainer biographies\" href=\"\/pages\/instructor-biographies\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Course Outline\" border=\"0\" alt=\"Course Outline\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/CourseOutline.jpg?n=2216\"\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eDay 1: 8:30 a.m. – 5:00 p.m.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003e\n\u003cb\u003eOverview of the drug development process:\u003c\/b\u003e Discovery through post-market\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eWorking in a regulated environment:\u003c\/b\u003e Definitions of GLP, GCP, and GMP; Global regulatory authorities – mission and responsibilities; Regulations – US (Code of Federal Regulation); ex-US (International Conference on Harmonization – ICH GCP E6; EU Directive); forgotten elements\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eFundamentals of GLP, GCP and GMP:\u003c\/b\u003e Non-clinical testing (GLP) – elements and examples of non-compliance; Clinical research (GCP) – elements, sponsor responsibilities, examples of non-compliance; Investigational product manufacture (GMP) – elements and examples of non-compliance\u003c\/li\u003e\n\u003cli\u003e\n\u003cb\u003eQuality Management of GCP Laboratories:\u003c\/b\u003e Laboratory Quality System identification, Qualifications, Outsourcing, Accreditation, Challenges with global studies\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Interactive Activities\" border=\"0\" alt=\"Interactive Activities\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/InteractiveActivities.jpg?n=4477\"\u003e\u003c\/p\u003e\n\u003cul class=\"Abstract\"\u003e\n\u003cli\u003eSituational reviews of practical scenarios\u003c\/li\u003e\n\u003cli\u003eCritique of current FDA Warning Letters\u003c\/li\u003e\n\u003cli\u003eGroup discussions\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cimg title=\"Registration Fees\" border=\"0\" alt=\"Registration Fees\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/RegistrationFees.jpg?n=6142\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eRegistration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003eSpecial rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cb\u003e\u003ci\u003e\u003ca title=\"Click here for our seminar cancellation policy\" href=\"https:\/\/stage.barnettinternational.com\/EducationalServices\/SeminarFAQs.aspx\" style=\"color: rgb(0, 0, 255);\"\u003eClick here for our seminar cancellation policy\u003c\/a\u003e\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cimg title=\"Accreditation Information\" border=\"0\" alt=\"Accreditation Information\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services\/images\/LiveSeminars\/AccreditationInformation.jpg?n=7031\"\u003e\u003c\/p\u003e\n\u003cp class=\"Abstract\"\u003e\u003cimg title=\"ACPE Logo\" border=\"0\" alt=\"ACPE Logo\" src=\"https:\/\/stage.barnettinternational.com\/uploadedImages\/Barnett_Educational_Services_-_Under_Construction\/ACPE%20Logo.JPG\"\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE# 0778-0000-14-051-L01-P. Released 9\/14.\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eHold this course at your company!\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp align=\"center\" style=\"color: rgb(0, 0, 255);\"\u003e\u003cb\u003e\u003ci\u003eFor more information, contact Naila Ganatra at (215) 413-2471.\u003c\/i\u003e\u003c\/b\u003e\u003c\/p\u003e","products":[],"url":"https:\/\/www.barnettinternational.com\/collections\/good-clinical-practice-for-the-laboratory-scientist.oembed","provider":"Barnett International ","version":"1.0","type":"link"}