INSIGHTS ON REGULATORY COMPLIANCE

• Lifecycle Planning For Containment And Delivery Of Biologics Drug Products

  Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development to set yourself up for future success.

• Host Cell Impurities, Bioassays, Micro-Flow Imaging

  Ensuring the safety and efficacy of cutting-edge biopharmaceuticals hinges on meticulous quality control measures. Explore the role of qPCR and MFI in safeguarding drugs from potential contamination.

• SAP S4HANA Implementation: Commissioning, Qualification, And Validation

  Explore how CAI helped one company navigate complications when implementing SAP and how new solutions are being developed, validated, and implemented to establish this new global ERP system.

• The Problems With Construction Quality In Life Sciences

  In the mission-critical construction industry, quality management is underperforming. Understand the importance of quality control in life sciences commissioning processes and construction programs.

• A Guide To Writing Effective SOPs In Life Sciences

  8/17/2022

  We share some SOP guidelines that can help you build and manage documents that are easily accessible, relevant, and something your team can consistently rely upon.

• Achieving Next-Level Quality With Digital Technology In Manufacturing

  9/30/2022

  Learn how a modern Manufacturing Execution System (MES) is using digital production records to help manufacturers regulated by the FDA improve their quality and efficiency goals.

• Round 2: Mastering NDA Submission And A Resubmission Rescue Mission

  3/2/2023

  This biopharmaceutical company had to overcome trial master file (TMF) transfer from a previous licensee, staff turnover, and then a resubmission of its NDA.

• Longhorn's Path To A Universal Influenza Vaccine

  12/2/2022

  Thanks to the long-term planning of one biopharma family and some help from the U.S. Army, a universal influenza vaccine is coming soon to a clinical trial near you.

• Vaccines: Cleaning Regulations For Production

  12/1/2022

  Learn about the critical cleaning and disinfection steps as well as the associated regulations manufacturers follow in their facilities to ensure product safety and the highest standards of product quality.