1. QbD Technologies: Workshop for Risks Analysis Incorporating Risk Management for Technology Transfer

2. Challenge Pharmaceutical Analysis: Fall 20142  Worlds most complex bioreactor: Homosapien  Small variations can have catastrophic effects DevelopmentClinicalDiscovery Pharmaceutical Analysis Tools help maintain safety and quality throughout

3. ICH Quality Risk Management Guideline  “Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries.”  “It is commonly understood that risk is defined as the combination of the probability of occurrence of harm and the severity of that harm”  The purpose of this document is to offer a systematic approach to quality risk management  http://www.ich.org/fileadmin/Public_Web_Site/ICH_Prod ucts/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf http://www.ich.org/fileadmin/Public_Web_Site/ICH_Prod ucts/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf

4. Risk Management Approach  Failure Mode and Effects Analysis (FMEA)  Developed by the US military back in the 1940’s  Some Basic Steps  Break down the product and process into its components or steps  Identification and assessment of the following for every item listed: function(s), potential failure mode(s), failure mode effect(s), failure mode cause(s), and controls for detecting or preventing the failure mode(s);  Evaluation of the risks associated with the failures modes and prioritizing them according to importance;  Implementation of corrective actions to minimize the occurrence of the more significant failure modes; Risk Management is a methodology to derive a process and product independent measure of performance related to the clinic

5. Take Home Clarification  You need to choose a technique from the following list:  Fill out cover sheet on workbook describing what technique:  CE, UV/VIS, Raman, NIR, Mass Spectrometry, NMR, Fluorescence, PAT application (must be one of these)  Fill out the Severity/Probability/Detection for at least 10 parameters of interest for failure  For 3 of the above – fill out how you would de-risk and rationale  Fill out your conclusions on the cover sheet  Email it prior to entering exam  Time estimates < 60 minutes  Worth 15 points!