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| The PDA Pharmaceutical Microbiology Conference 2025 marks two decades of advancing microbiological science and practice. This milestone event brings together the global microbiology community, including experts from industry, academia, and regulatory agencies, to explore the evolving landscape of pharmaceutical microbiology. This year’s theme, Microbial Resilience: Today’s Response, Tomorrow’s Plan, reflects our focus on navigating present-day challenges while building robust strategies for the future. |
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| Closed Sampling: Crucial For Aseptic Processing | Webinar | MilliporeSigma | Explore the critical role of closed sampling in bioprocessing by gaining insight into regulatory frameworks, system integrity, and aseptic practices essential to ensure compliance and product quality. |
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By Marcelo Trevino, independent expert | Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points. | |
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By Ajaz S. Hussain, Ph.D., independent pharmaceutical regulatory science expert | Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management. | |
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By A. Walsh, et. al. | A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs. | |
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By Jesper. M. Wagner, NIRAS | Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability. | |
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