Pharmaceutical and Medical Device Good Manufacturing Practices - Similarities and Differences - Webinar By GlobalCompliancePanel 2011

Key Topics

• Differences between Medical Devices and Pharmaceuticals
• Introduction to Quality and Compliance Concepts
• Standards of Quality
• Scope of the GMPs and the Quality Cycle
• A Comparison of Definitions and Terms
• The Shifting Paradigm to Focus on Customer and User Satisfaction- The Quality Systems Approach
• Comparing Design Requirements
• Comparison of Personnel and Management Expectations
• Comparing Equipment Controls
• Comparing Master Records
• Comparing the Control of Processes
• Comparing Material and Incoming Controls
• Laboratory Controls and Device Evaluation
• Packaging and Labeling Comparisons
• Problem Solving-Deviations, Complaints, and CAPA
• Holding, Distribution, & Returns
• Current Trends
• Part 11

Who should Attend

Quality control, Quality, Operations working in the FDA regulated medical products industry (Pharma & Device) in the design, Regulatory Affairs, Regulatory Approval, scale-up, maintenance of quality systems, commercialization, Companies working with Combination Products, Suppliers providing materials and contractors supplying outsourcing s services to FDA regulated clients.