Government

WHITE PAPERS AND CASE STUDIES

• Best Practices For Internal Quality Audits In Life Sciences

  Discover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Providing Enhanced Manufacturing Data To Contracting Companies

  The life sciences sector is projected to reach $220 billion by 2030. Examine the growth of CDMOs and CMOs, emphasizing the need for digitalization to meet client demands and regulatory standards.

• Relieving The Strain Of Publishing During Regulatory Registration

  Go inside how an expertly handled NDA submission for a biopharma company ensured timely FDA approval despite challenges.

• The Evolution Of Antibody-Drug Manufacturing

  Explore how ADC chemistry and manufacturing have evolved, the challenges this dynamic growth has created, and how CDMOs are adapting to these changes to meet customer needs, now and in the future.

• Is The Water Sector Ready For AI?

  Despite AI's potential to transform the water sector, fewer than half of organizations are fully ready for adoption. The biggest challenges are procedural and cultural, like fear of change and workforce readiness. Focus on these internal barriers to gain measurable efficiency and sustainability benefits.

• AMERICAN Plays A Role In Rebuilding Puerto Rico's Infrastructure

  AMERICAN is helping rebuild Puerto Rico’s vital water infrastructure after Hurricane Maria, supplying American-made products to strengthen resiliency for 3.5 million residents and millions of annual visitors.

• Breaking Through Barriers With Integrated Trial Optimization

  In today’s complex clinical trial environment, optimizing trial design requires a multidimensional strategy that balances scientific rigor with real-world constraints.

• Developing Effective Procedures

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

• Simplify CAPA In 7 Steps

  Discover how to streamline corrective action/preventive action (CAPA) management in regulatory environments in 7 steps.

• Compound Library Consortium

  Explore how a novel approach to enhancing drug discovery efforts can significantly improve the chances of identifying promising drug candidates, ultimately accelerating the path from discovery to development.

• Meet Regulation Requirements With RTU Vials And Cartridges

  Sterile manufacturing remains vital, with resilient supply chains preventing shortages. Industry and regulators prioritize integrity as demand surges, making it the fastest-growing pharmaceutical segment.