Insights On Regulatory Compliance

1. Developing Effective Procedures 10/21/2024

   Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

2. Unlocking The Potential Of Digital Transformation Tools In The Biopharmaceutical Industry 10/4/2024

   Why do many BioPharma organizations still struggle to gain the crucial benefits they desire from their data and digital transformation tools?

3. Single-Use Strategies For Uninterrupted Microbial Monitoring 2/22/2024

   Watch as Emad Albarouki, a microbiology and sterility assurance specialist at Particle Measuring Systems, discusses the best practices for using BioCapt® Single-Use in continuous microbial active air monitoring.

4. Intro To USP <1062> - What It Is And Why You Should Use It 7/20/2023

   Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.

5. Empowering Healthcare Decision-Making 10/21/2024

   FormularyDecisions, now part of Cencora, has evolved significantly since its acquisition in 2019. Let's reflect on its journey, impact, and the future of formulary submissions in the digital age.

6. AI Implementation To Enhance Quality 2/11/2025

   Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.

7. Building An Effective Contamination Control Strategy For Final Sterile Filtration 8/13/2024

   Watch to learn about important considerations for final sterile filtration throughout product development and for performing pre-use post-sterilization integrity testing.

8. Resolute® BioSC Pilot: Designed For Effective And Consistent Chemical And Microbiological Cleaning 10/10/2024

   Issues related to cleaning and cleaning validation are some of the most common concerns that arise in FDA Warning Letters. Discover how to ensure you pass your cleaning validation tests.

9. The Importance Of 503B Facilities In Drug Manufacturing Today 10/5/2023

   Here, we share one of the best ways to ensure sterility in aseptic compounding operations and how 503A and 503B pharmacies can achieve the adaptability they need to scale their operation.

10. Optimizing Cleaning And Disinfection As Part Of An Effective CCS 6/6/2024

    Watch to explore the relationship between a Contamination Control Strategy (CCS) and the development of a robust cleaning and disinfection program for cleanroom environments.