INSIGHTS ON QUALITY CONTROL

• Lessons From FDA 483s And Warning Letters: Cleanroom Compliance

  Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

• Active Air Sampler Comparison In Remote Settings

  Discover how optimized air sampler geometry improves microbial collection efficiency and continuous environmental monitoring accuracy to safeguard critical cleanroom operations.

• Quantifying Endotoxins Via Absorbance Or Fluorescence

  Find out how endotoxin assays use Factor C activation to generate measurable absorbance or fluorescence signals, with guidance on selecting detection formats and implementing scalable workflows.

• Human Performance In Pharma: Strengthening The Biotech Workforce

  Transforming the pharma workforce requires strategic partnerships and a shift toward behavioral and operational readiness, moving beyond simple technical training to ensure performance and compliance.

• The Pain Of Change – Could Suppliers Be Part Of The Cure?

  10/15/2024

  Change is a constant in the pharma industry, but it doesn't have to be painful. Discover how suppliers can help ease the burden of regulatory change management and streamline essential processes.

• Designing For cGMP Compliance: Facility Requirements And Best Practices

  6/26/2026

  Integrating process flows, HVAC controls, and cleanability during initial cleanroom planning ensures cGMP compliance and mitigates long-term contamination risks.

• Ask Us Anything: Mark Benger On Solid-State Strategies For Drug Development

  7/23/2026

  Mark Benger, Site Director at Cambrex Edinburgh, on solid-state characterization as an insurance policy — front-loaded work that quietly determines whether a program survives the jump from kilos to tonnes.

• Straight From The Source: A Live Q&A With The Inventors Of KinetiSol™

  5/22/2026

  Experts discuss a solvent-free fusion process for amorphous solid dispersions, highlighting formulation flexibility, scale-up, process control, and early strategies to reduce risk and support commercialization.

• Learn, Confirm, Then Scale: A Leader's Guide To Transforming QC

  1/21/2026

  Legacy lab systems hinder innovation and scalability. Explore a proven approach to modernize QC through cloud-based LIMS, starting with small pilots that validate strategy and reduce risk.