INSIGHTS ON QUALITY ASSURANCE

• FDA's New Flexible CMC Framework For CGT

  The FDA is rethinking CMC oversight for cell and gene therapies, prioritizing science‑based justification over rigid validation models. Learn how this lifecycle‑focused approach could reduce burden.

• What Happens When You Refuse To Compromise On Sustainability?

  Discover how an empty building shell became a sustainable nanomedicine hub and achieved 47% energy savings and 88% fewer emissions, which sets new standards for innovation in the biologics industry.

• Advances In Analytical Method Selection And Technology Transfer

  Successful analytical method transfer is crucial for product quality and regulatory compliance. Learn best practices for tech transfer, including how gap assessments mitigate common risks and streamline bioprocessing.

• A CCS Is A Purpose-Built Machine, Not A Black Box: Understand The Workings

  Learn how to transform your contamination control strategy into a dynamic operational framework that identifies risks and strengthens facility control.

• What Pharmacies Often Miss In USP <800> Compliance

  5/27/2026

  Master USP <800> compliance by transitioning from standalone equipment to an integrated system design. Review key protocols for a multi-layered strategy to mitigate cumulative drug risks.

• Quality Time With Oliver: Guest David DiVaccaro - Part 2

  7/14/2026

  Gain practical insights into the future of package validation, including smarter aging studies, science-based decision-making, and how validation professionals can move beyond legacy practices.

• Why You Need Spare Parts On Hand For Pharma And Lab Equipment

  8/19/2026

  Advanced spare parts planning can reduce downtime. Learn why precise component specifications matter and how seemingly identical parts can differ significantly in quality, performance, and failure risk.

• Secondary Packaging: Cartoning And Kitting

  6/23/2026

  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.

• How LIMS Supports QC Scaling At Forge Biologics

  1/21/2026

  Modernizing QC workflows with cloud-based systems eliminates paper inefficiencies, reduces errors, and accelerates reporting. Discover how streamlined processes improve compliance and enhance data visibility.