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A central aspect of Quality by Design (QbD) and Quality Risk Management (QRM) is risk mitigation, and manufacturers are increasingly looking for ways to build quality into each production stage. One way to address related risks is by implementing a Question-based Review approach. Explore this approach and its advantages.
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The latest revision to EU GMP Annex 1 introduces several changes, many of which aim to resolve ambiguities and update language to align with current technical and regulatory standards, including the requirement for PUPSIT. Gain insight into these updates and the components that should be part of a PUPSIT risk assessment.
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The uncertainties associated with scaled-up manufacturing often delay process-specific filter validation until Phase 3 clinical trials. However, if initial risk assessments within the CCS reveal a specific risk, testing can be conducted to address it. Learn about a program developed to aid in risk mitigation before process-specific filter validation is performed.
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How To Plan For Trouble-Free Filter Validation
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Join this webinar to discover best practices to ensure that process-specific filter studies are performed as expected and that the data generated supports the end user’s intended final sterilizing-grade design space.
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