Raw Materials Risk Management in GMP Facilities: Avoiding GMP non-Compliance Due to Raw Material Issues 2013

Topics

• Common risk management practices
• FDA requirements for raw material management at GMP facilities
• Product specific raw material issues: chemical, biologic and botanical raw materials
• Vendor selection and validation requirements
• FDA’s common findings and possible resolutions
• Suggested quality control measures
• Regional and multinational raw material providers
• Trends in FDA inspection of raw material processes
• Raw material risk management in the global setting

Who should Attend

• Managers of GMP facilities
• Compliance/Regulatory affairs professionals
• QC and analytical methods scientists and managers
• Supply chain managers
• Purchasing and Materials Control managers
• QA directors, managers and personnel
• Senior managers of companies using CMOs
• GMP site personnel
• People investing in FDA-regulated product development projects