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. Raw material management is particularly challenging because it is mostly based on performance of independent vendors out of direct control of the GMP facility. Hence it is important for all GMP manufactures to implement robust methods for raw material risk management.

This FDA GMP training will help you understand the current requirements for raw material management with tips for 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.

Course Objective

This webinar is a must for GMP facilities or facilities trying to be GMP compliant irrespective of the kind of product manufactured: drug, biologic, diagnostic kit, medical device or dietary supplements. This presentation will help you understand the current requirements for raw material management with tips about practical implementation. We would discuss the 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. Attendees will be able to use the training to evaluate existing programs and get tips about assuring compliance with FDA requirements. Impact on compliance with other regulatory requirements in other parts of the World will also be discussed.

Course Outline

• 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

Target Audience

• 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