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WHITE PAPERS AND CASE STUDIES

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• A Review Of The Changing Trends And Use Of eCOA In Clinical Trials

  Delve into how electronic clinical outcome assessments are being transformed through new technologies, the maturation of digital organizations, and increased endorsement from regulatory bodies.

• ProPharma Supports A Contract Manufacturer's Form 483 Response

  Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.

• Successful Cell-Based ADA Collaboration In mRNA Gene Replacement Therapy

  A biotech firm developed a rapid, sensitive, cell-based ADA assay through collaborative innovation, reducing variability and turnaround time while improving performance for mRNA gene therapy.

• Intelligent Automation For MDR & IVDR Content

  Learn how automation can help fulfill new MDR/IVDR requirements and optimize existing labeling and documentation operations while meeting compliance.

• OEE And Product Inspection

  Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.

• Optimal COA Measurement Strategy In Modern Oncology Trials: Insights

  Explore the challenges and opportunities in implementing patient-reported outcome measures (PROMs) in oncology trials. This article discusses the recent FDA draft guidance, emphasizing how more targeted PROM strategies could lead to better medication labeling and patient care in cancer treatment.

• Disinfection For Purified Water Loop For Kamada Pharmaceuticals, Israel

  An Atlantium HOD™ (Hydro-Optic Disinfection) UV system was installed at the outlet of a PW tank to serve as the primary disinfection barrier, with water circulating through the system at 6m³/hr before reaching the points of use.

• 5 Ways Manufacturers Optimize Consumables Programs With RFID

  RFID technology helps manufacturers who rely on repeat sales of consumable components combat threats to profitability and performance, while ensuring superior operability for their end-use customers.

• Mobile Advanced Therapies Facility

  Discover NIH's innovative solution to clinical-stage viral vector production: See how two mobile cGMP facilities deliver adaptability and compliance to Bethesda's National Institute of Health.

• The Effect Of Mixing Homogeneity In Retentate Vessel

  Discover a novel analytical method enhancing TFF diafiltration insights that deliver superior mixing, reliable scale-up, and breakthrough interpretation of diavolume performance.

• Advanced Spectral Measurement Systems And Semrock Optical Filters

  Examine how advanced spectral measurement systems (SMS) platforms ensure precise and reliable spectral measurements, especially in scenarios involving deep blocking and steep spectral edges.