Special Topic: Risk Management in Combination Product Development

This event is now offered in a new entirely virtual format.

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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

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