Pharmaceutical Risk Management Tools: Getting the Most Out of ICH Q9
May 20 - 21, 2008
Amsterdam
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This comprehensive quality system workshop will benefit
professionals who are involved in managing and operating in
the ICH Q8, Q9 and Q10 areas, as well as those who
interact with PAT and QbD programs, including:
• PAT and QbD Team Leaders and Members
• Quality and Efficiency Personnel
• Manufacturing Operations Personnel
• Product Development Teams
• Technology Transfer Personnel
• In-process and Finished Goods Analysts
• Analytical Instrument and Manufacturing Equipment
Suppliers
• Managers tasked with improving pharmaceutical operating
efficiency
Description
ICH Q9 is one of the three “cornerstone” 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.
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.
This course provides both principles and practices for
successful ICH Q9 implementation.