Newsletter | October 31, 2024

10.31.24 -- CDER Wants Your Input On Improving Integrated Reviews

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Successful analytical assay development relies on a profound understanding of method development theories and the ability to prioritize the right parameters. The resulting, well-structured product life cycle drives production efficiency and higher-quality therapeutics. Each failure in method development or execution delays the delivery of crucial products to patients. Learn more.

FOCUS ON REGULATORY

CDER Wants Your Input On Improving Integrated Reviews

CDER recently moved from sharing reviews from individual disciplines in public documents to an Integrated Review, which includes conclusions but much less detail.

Preparing For FDA Pre-Approval Inspection: Quality And Regulatory Topics

Consider these strategies for meeting quality and regulatory requirements in cell and gene therapies that can also help to identify issues early, reduce risks, and prevent delays and rework.

REGULATORY SOLUTIONS

21 CFR Part 11 Pharmaceutical FDA Compliant Software - MasterControl, Inc.

FOCUS ON ANALYTICS & QUALITY

3 AI Breakthroughs Revolutionizing Pharma Tech Ops At Roche

Roche has pushed through so-called "pilot purgatory" and rolled out artificial intelligence solutions in the real world. Two of its data leaders describe three case studies.

Digital Transformation - The Power Of Your Data

Discover how you can circumvent numerous recirculations during the ultrafiltration process step, boost downstream bioprocess yield, and identify and resolve process inefficiencies.

Digital Solutions Advance Your mRNA Manufacturing Workflow

Explore the advantages of paperless manufacturing, the importance of incorporating a digital strategy early in the process, and how digital solutions for mRNA manufacturing can help enhance production.

How Two Life Science Leaders Unlocked Pharma 4.0 Success

Gain valuable insights from digitalization leaders on how some life sciences manufacturers are successfully scaling their Pharma 4.0 initiatives beyond the pilot stage and paving the way forward.

ANALYTICS & QUALITY SOLUTIONS

Microcalorimetry: ITC & DSC - TA Instruments

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