Overview: This webinar explains the regulations and provides guidance on their implementation. We cite the regulations and discuss the FDA's intent as provided in the preamble to the regulations. We explain the advice offer FDA's QSR Manual. This guidance helps manufacturers implement the regulations using explanation and sample procedures and forms. The FDA has recommended, in Warning Letters, that manufacturer's obtain a copy to help them come into full compliance. Why should you attend:Do you know when you can use a visual check and inspection for damage at receiving acceptance?Do you link supplier evaluation and selection to your receiving acceptance activities?Can you use product in production even if you have not fully completed the receiving inspection or tests?If you inspect product, do you have to record all the quantitative measurements, or can just record the inspection results?If you use sampling plans, can you show the Operating Characteristic (OC) curve for the plan and explain what it means?Areas Covered in the Session:The QSR Requirements for Acceptance ActivitiesProceduresRecord keepingReceivingIn-processFinalAcceptance StatusQSR ManualUnderstanding the definition of a productWhat to include in acceptance activity proceduresUnderstanding and stating acceptance criteriaSupplier testing as part of receiving acceptanceContract laboratory testing as part of receiving inspectionSampling plans and the OC curveWarning lettersAnalysis of Warning Letters that cover all aspects of acceptance activitiesLearning objectives:Understand the regulatory requirements for acceptance activitiesExplain the relationship between supplier selection and receiving acceptanceKnow the required documentation when the supplier performs the inspection and testsState the FDA expectation for quantitative data in acceptance activity recordsExplain the use of sampling plans and describe the OC curveState the FDA expectation on using components before completing acceptance activitiesWho Will Benefit:Quality ManagersQuality ProfessionalsProduction ManagersProduction SupervisorsManufacturing EngineersProduction EngineersDesign EngineersProcess OwnersPurchasing ProfessionalsInspection and test ManagersDan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management.GlobalCompliancePanel Phone: 800-447-9407Fax: 302-288-6884