Webinars>>​Risk Management in GMP Facilities
Raw Materials Risk Management in GMP Facilities: Avoiding GMP Non-Compliance Due to Raw Material Issues

Raw material related issues continue to be one of the most common findings during GMP inspections 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. The real challenge in raw material management lies in the fact that it is mostly based on the performance of independent vendors out of direct control of the GMP facility. Hence it is important for all GMP manufacturers to implement robust methods for raw material risk management.
Why should you attend:

This seminar 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 seminar 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.
Topics Covered in the Session:
  • 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
Date: August 12, 2019
Time: 12 PM EST     Duration: 60 Minutes

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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com