GUIDELINE TO:
HOW TO PREPARE A RISK ASSESSMENT FOR CROSS CONTAMINATION
January 21, 2010 WEBINAR
NOON - 1:30 pm EST
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.
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
- 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
FEE: $365 for one person.
Call for special per person discounts for multiple participants from your company.
I nstructor: Stephanie Wilkins PE
Stephanie Wilkins, PE, Lean Six Sigma Green Belt, is president of PharmaConsult US, Inc., which provides potent compounds containment consulting to the Pharmaceutical industry. Wilkins has over 25 years of professional experience in project management, engineering and validation solutions for the pharmaceutical/biotech industry including research, development, pilot plant and manufacturing facilities. She is co-Chair of ISPE Risk-MaPP Baseline Guide Task Team and is a member of the ISPE International Board of Directors.
610-399-4897
ECCWEB152
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