INSIGHTS ON QUALITY ASSURANCE

• How Modern EQMS Solutions Are Powering Pharma’s Digital Revolution

  If your company isn’t at least planning on implementing an EQMS solution or other advanced digital tools, learn why now is the time to start.

• Why Perform A Product D-Value Study?

  Follow our discussion on non-heat sensitive aqueous liquid product sterilization and the use of the Overkill method and Bioburden/BI method.

• Digitalizing Biopharma Manufacturing Step-By-Step: Part II

  Explore a modular approach to digitalization involving the development of electronic logbooks and procedural guides, weigh and dispense processes, and Master Batch Records/Electronic Batch Records.

• ICH Quality Risk Management Guidelines For Biopharma Manufacturing

  Explore the key changes to the ICH Quality Risk Management guidelines that aim to optimize efficiency, effectiveness, and scientifically grounded control strategies.

• Optimizing Process Loads For VHP Decontamination

  2/20/2024

  Explore how CAI helped a company rescue a failing CQV project and create more efficient Vaporized Hydrogen Peroxide Material Air Lock (VHP MAL) Loads to enhance operational efficiency.

• Do You Have an FDA Audit Process in Place?

  2/23/2023

  Ease the stress of a U.S. Food and Drug Administration (FDA) visit to your facility by learning how to maintain a state of FDA audit process readiness.

• Efficient Lab Inventory Manager

  1/10/2023

  See how LANEXO Inventory Manager works in a lab, and learn about the main features you can use.

• Elevating Quality Beyond Compliance

  4/23/2024

  See how one company was able to connect its quality processes, improve collaboration across business functions, and address the needs of its digitally-aware workforce.

• CAPA Management Improvement Process

  9/15/2023

  Gain insight into how a small team of experts worked to collect, trend, and understand the CAPA generation and completion process of a client struggling with on-time batch release, missed CAPA closure deadlines, and more.