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| Webinar: Navigating AI Compliance in Life Sciences: FDA Policy Insights for AI Governance | Discover how to harness AI in life sciences without compromising compliance. In this webinar, FDA AI policy expert Danielle Dorfman Faruq and Renee VonBergen explore AI governance, data integrity, human oversight, transparency, monitoring, and validation. Gain practical strategies to implement compliant AI, strengthen quality processes, and build a scalable roadmap for successful AI adoption. Click here to learn more. |
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| Layer By Layer: 3D Screen Printing And The Future Of Drug Development | Article | By Klaus Kuhne, Laxxon Medical and Steven Facer, Adare Pharma Solutions | 3D screen printing can produce tablets across a range of release profiles, from conventional immediate release tablets to multi-compartment drug delivery systems that mix different release profiles. |
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By Peter H. Calcott, Ph.D., Calcott Consulting LLC | In March 2026, the FDA issued a new draft guidance titled Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection Guidance for Industry. Let's take a closer look. | |
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INDUSTRY INSIGHTS CONTINUED |
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| Building R&D Knowledge Into GMP Documentation | Article | Dalton Pharma Services | Integrating R&D knowledge into GMP documentation ensures consistent aseptic powder fill‑finish processes by capturing material insights, defining controls, and enabling reliable manufacturing. |
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| Enabling Pharma 4.0 With OCELOT System Control | Webinar | Asahi Kasei Bioprocess | Discover how incremental steps in digitalization and Data Integrity by Design can bridge the gap to Pharma 4.0, enhancing process efficiency and workforce capability without the need for a total overhaul. |
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| Leveraging Integrated Electronic Laboratory Notebook | White Paper | By Zach Martin, Bend Bioscience | Integrating lab notebooks with inventory and asset tracking boosts accuracy and traceability. Real-time visibility cuts errors, speeds decisions, and supports compliant, scalable pharma development. |
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| Secondary Packaging: Cartoning And Kitting | Case Study | Praxis Packaging | Fast deployment, scalable production, and rigorous quality control enabled the delivery of over 20 million complex kits in eight months, demonstrating how efficient operations can meet urgent demand. |
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| Reflecting On 2025: Innovation And Investment | Article | ROIS | As capacity expands and capabilities mature, CDMOs with global scale and advanced injectable expertise are becoming critical partners for bringing complex sterile drug products to market. |
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| Setting The Tone For A Fill/Finish Engagement Program | Guest Column | Afton Scientific | The initial 90 days of a fill/finish CDMO partnership establish lasting communication patterns, clarify mutual responsibilities, and test problem-solving capabilities critical to program success. |
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| Your Guide To Precise And Robust Separation Methods | Application Note | Waters Corporation | Review a detailed guide to characterizing GLP-1 receptor agonists that covers advanced LC-MS and SEC-MALS workflows for impurity profiling, stability testing, and aggregate analysis. |
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