Hybrid Quality Systems For Pharmaceuticals - Combining ICH Q7A & Part 210-211 - Webinar By GlobalCompliancePanel 2011

Topics

• Jurans`s Quality Loop And Its Application T o Our Industry
• Quality 101
• Comparison of Part 210/211 & ICH-Q7A
• The Scope of the GMP`s
• Constructive Criticism of Part 210/211 & ICH-Q7A
• Praises and Accomplishments of Part 210/211 & ICH-Q7A
• A Quick Comparison to ICH & ISO
• The FDA Quality Systems Approach to the Pharmaceutical GMPs
• Planning and Implementing the Hybrid System

Who should Attend

• Interdepartmental functions associated with scaling up and commercializing a new medical product
• Quality control, Quality, engineering, regulatory, IT and manufacturing staff working in the FDA regulated industry in the development and manufacture of medical products
• Suppliers and software vendors, servicing the FDA regulated industries, who want to better understand the customer’s needs and requirements
• Regulatory Affairs working on approval of combination products