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.
