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| Webinar Series: Managing Method Variability - A Foundation for Risk-Based Change | Join us for a three-part webinar series featuring regulatory expert Peter Baker of Live Oak QA, a former FDA Investigator of the Year. This series explores how to identify, monitor, and control variability within analytical workflows, offering real-world insights and practical strategies for method adjustment while staying compliant. Each session includes a live Q&A to encourage interaction and address specific challenges. Register now |
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| Unlocking Agility And Efficiency In Biomanufacturing | Article | By John Stewart and Rasmus Pedersen, Ph.D., FUJIFILM Biotechnologies | Discover a standardized yet flexible modular biomanufacturing system designed to accelerate timelines, improve scalability, and enhance quality while reducing costs and environmental impact. |
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| Pursuing Automation Excellence With A Comprehensive Solution | Article | By Abimael Rios, Asahi Kasei Bioprocess | Automating your bioprocessing workflows can significantly improve quality and scalability. To reap the benefits, implement plant-wide control software that enables seamless integration and efficiency. |
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| Streamline Drug Development With A Lab Informatics Platform | Article | By Lisa Postava, product marketing manager, IDBS UK HQ | Learn how a tiered approach to ADME-Tox studies can help researchers navigate early-stage preclinical research and mitigate the risk of costly failures in drug development. |
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| Annex 1 Compliance Guidelines For Biological Indicator Users | Article | By Crystal Hostler, Mesa Laboratories | Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators. |
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| Enabled Form Selection For Oral Drug Products | Webinar | Lonza | Review the role of solid form screening and PBPK modeling to enable accelerated timelines desirable in early-phase drug development. Examine formulation maps for ASDs and key criteria for salt screening. |
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| Webinar: Innovation & Efficiency - Visual Inspection in the 21st Century | Join InQuest Science's webinar with Roy Cherris, a leading expert in visual inspection systems, as he shares 40+ years of Quality Assurance expertise. Learn how to optimize visual inspection efficiency, reduce errors, and achieve compliance with FDA and global guidance. Discover how Identifier Software enables paperless Pharma 4.0, consolidates big data, and transforms Quality by Design through digital relational databases. Click here to learn more. |
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By Frank Balonis | A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools. | |
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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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