FDA产品质量的风险评估原则RiskAssessmentPr到inciplesfortheProductQualityInitiatives.pptVIP

Risk Assessment Principles for the Product Quality Initiatives H. Gregg Claycamp, Ph.D., CHP Center for Veterinary Medicine Office of New Animal Drug Evaluation hclaycam@cvm.fda.gov June 25, 2003 Outline Overall Premise and Questions Basics of Risk Analysis Possible Stages of Risk Assessments for PQ Initiatives Risk Ranking Model for a PQ Initiative? Pilot Scale Conclusions Premise: Links Among Process (GMP) Risks and Patient Risks are Lost Goal: Re-Link cGMP (PQ) Risks with Actual Risks to the Patient The Question… Can Risk Management theory, tools, practice and philosophy be employed to r