Speaker: Joy McElroyKey Take AwayGet a proper contrast and comparison of GMP and Good Laboratory Practices (GLPs), CFR part 58, for conducting nonclinical laboratory studies that support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.OverviewThe objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices training.Why Should You AttendGood Laboratory Practices training (GLPs), CFR part 58, are a set of guidelines for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA. GLPs are not enforceable by law. They do not include manufacturing of product. GLPs are for non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety. This does not include studies utilizing human subjects, or clinical studies, or field trials on animals.Areas Covered In This WebinarGLP: Good Laboratory PracticeGLP is an FDA Regulation TrainingDefinition of GLPsHistory of GLPsWhy was GLP Created?Objectives of GLPMission of GLPInstrumentation ValidationAnalyst CertificationLaboratory CertificationGrounds for DisqualificationConsequences of NoncomplianceReinstatement of a Disqualified FacilityLearning ObjectivesWhat are Good Laboratory PracticesWhy were they createdWhat is the objective of GLPs and how are they associated with GMPs and SOPsStatistical procedures for data evaluationInstrumentation validationAnalytical and laboratory certificationDocumentation and maintenance of recordsConsequences of noncomplianceDisqualification and reinstatementWho Will BenefitQuality Assurance PersonnelQuality Control PersonnelResearch and Development PersonnelRegulatory Affairs PersonnelProject ManagersManufacturing ManagersValidation EngineersInternal Auditing PersonnelMicrobiology PersonnelAuditorsLevelBeginner