Regulators are increasingly adopting risk-based approaches to compliance.  Cross-contamination remains a high interest for regulators especially when high hazard products are manufactured in multi-product facilities.  Come hear the latest regulatory thinking and updates on how to prepare a risk assessment for cross contamination.

This webinar will guide you through the thinking and rationale behind preparing a risk assessment for cross contamination.  The interactive exercises will allow you to practice what you learn.

In this webinar you will:

• Learn which Agencies are embracing risk-based strategies

• Identify the two primary principles of quality risk management

• Examine the ICH Q9 process to determine acceptable risk

• Understand why we do risk assessments

• Identify what is a risk

• Learn about exposure routes and how the differ by population

• See why exposure control may be the key to risk management

• See why ADIs provide the starting point when assessing risk of cross contamination

• Get the tools to compare and prioritize risk

• Learn how to interpret RPN

• Use your new skills in interactive exercises

Instructor:  Stephanie Wilkins PE