Integrating FDA and Trending Requirements into your CAPA System

• Learn how to use trending to identify product quality issues
• Choose which technology to use for product quality trending

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Integrating ICH Q9 and ISO 14971 into the Quality System

• How ICH Q8 Product Development and Q10 Quality Systems impact the implementation of ICH Q9 Risk Management
• Why a company should develop a Risk Management process as part of a Quality System, when it is not a pharmaceutical regulatory requirement

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Conducting OOS and Non-Conformance Investigations

• Creating SOPs for FDA compliance
• Best practices for data collection

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