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

This webinar will help you understand the current requirements for raw material management with tips about practical implementation. It covers FDA’s expectations from GMP facilities regarding raw material vendor selection, measures for assuring acceptable quality of material supplied, expectations from quality control and documentation processes, and training requirements, with case studies.

Almost all FDA findings during GMP inspections include raw material related issues and most FDA warning letters to GMP facilities cite violations in raw material management. FDA's GMP inspectors pay special attention to the way raw materials are sourced, handled, controlled, used, and accounted for at a given facility. There is mention of raw material management in GMP regulations for all kinds of FDA regulated products – drugs, biologics, medical devices, diagnostic kits, dietary supplements and veterinary products.

Areas Covered:

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

Who Will Benefit:

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

Event Details:

Date:              Septomber 11, 2012

Time:             10:00 AM - 11:00 AM PDT

Cost:              $249 per attendee per computer terminal

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