Education Session
107 - Implementing Quality Risk Management: Using Risk Assessment to Speed Your Way to Drug Approvals
8 November 13.00-17.00
ISPE CEUs: 0.35
Tracks: Product DevelopmentQuality Systems
Sponsored by the PPD Community of Practice
What you will learn
Current ICH Q9 guidelines for quality risk management (QRM) and regulatory expectations create uncertainty in how to use the guidelines during inspections. This session will show how to use QRM to document control of the risks that exist and to create effective approaches to manage those risks. The tool that will be presented is Failure Mode and Effects Analysis or FMEA.
How you will Benefit
At the end of this session, participants will be able to:
- Understand how to use quality risk management tools
- Conduct a risk assessment
Who Should Attend
Quality assurance, engineering, validation, and production professionals
ISPE Communities of Practice (COPs)
PPD, API, Biotechnology, CU, GCLP, HVAC, IP, Packaging, PM, and SPP
View the ISPE Community of Practice (COP) Guide
Session Leader
- Andrew Jones, Director, Compliance, NPI, Global Biologics Supply Chain LLC USA
Session Presenters
- Robert Piperno, Senior Manager, GlaxoSmithKline USA
- Chris Rode, Principal Scientist, Centocor R&D USA