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Session 2: Overview of Risk Management
Session Chair(s)
Kimberly Trautman, MS
Managing Director
Trautman International Services, United States
Combination Products is evolving with global regulations and varied interpretations across regions. Yet manufacturers and health authorities have common objectives to bring safe, efficacious, and usable medical products to patients. This session will discuss the Risk-Based approach for Quality Requirements and Control Strategies. In addition, this session explores the life cycle of quality and risk management aspects and the need for continuous improvement to include:
- Quality by Design and Design Controls
- Essential Performance Requirements (EPR)
- Combination Products Risk Management
- Purchasing Controls
- Corrective and Preventive Action (CAPA)
- Post Marketing Safety Reporting (PMSR)
Learning Objective : - Compare and contrast pharmaceutical and medical device development requirements and principles for quality and risk management
- Principles of combination product risk management and how to incorporate those principles into practice
- Discuss the incorporation of the principles of combination product risk management into practice
Speaker(s)
Speaker
Susan Neadle, MS
Combination Products Consulting Services LLC, United States
Principal Consultant and President