ComplianceOnline, Online Event
2013-10-28
Why Should You Attend: 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. 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
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