ICH Q9: Managing Risk in Pharmaceutical Manufacturing Training Course :

ICH Q9 is one of the three &ldquo;cornerstone&rdquo; guidances proposed by the International Conference on Harmonization and undergoing adoption in The European Union, Japan and the USA. These policies, called Q8, Q9 and Q10, form an international platform that will dramatically improve efficiency and safety within the entire pharmaceutical life cycle. ICH Q8 and Q10 cover drug manufacturing and drug development by treating their individual operating steps as entities that are subject to variance. The platforms aim to reduce stepwise variance so that the likelihood of failure or rejection at the conclusion of the process is minimal. Both use riskmanagement techniques to accomplish their goals.<br><br> Risk management involves assessment of pharmaceutical unit operations for critical-to-quality attributes, evaluation of tolerable variance, measurement and control of those parameters and eventually, high release rates with minimal likelihood of recall or patient risk. Putting risk management into practice involves multivariate analysis of all development and production factors.<br><br> This course provides both principles and practices for successful ICH Q9 implementation.