Transcription of Corporate Compliance for the Pharmaceutical and …
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Corporate Compliance for the Pharmaceutical and …
Corporate Compliance for the Pharmaceutical and medical Device IndustriesBRIAN RIEWERTS, MPAP ricewaterhouseCoopersBaltimore, MD410-783-8920 DEBORAH RANDALL, JDArentFoxWashington, DC202-857-6341 Current Compliance Environment Compliance Program Design and Evolution Internal/External Audits of Company Practices CIAs, IROsand Key Negotiation Points Using SOP 99-1 To Set Agreed-Upon Procedures Discussion and Questions & AnswersPharmaceutical and medical Device IndustryNames in the News1. TAP Pharmaceuticals2. Bayer Corporation3. Schering-Plough4. Bristol-Myers SquibbShareholdersSenior ExecutivesManagementCompliance Officer?A Compliance program is a management process comprised of formal reporting structures and risk mitigation systems designed to motivate, measure, and monitor anorganization slegal and ethical performance around complex business s More Than GXPS imply Put - Compliance is Reaffirming Your Commitment to Uphold the Laws Which Govern Federal agenciesnConsumer Product Safety Commission, nDrug Enforcement Administration, nDepartment of Transportation, nEnvironmental Protection AgencynFederal Aviation Administration, nFederal Trade Commission, nFood and Drug Administration,nNuclear Regulatory Commission nOccupational Safety and Health AdminnSecurity and Exchange Commission State Laws International Laws1.
Corporate Compliance for the Pharmaceutical and Medical Device Industries BRIAN RIEWERTS, MPA PricewaterhouseCoopers Baltimore, …
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