INSIGHTS ON REGULATORY COMPLIANCE

• Perspectives On Performance, Scalability, And Regulatory Compliance

  Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.

• 5 Signs You've Outgrown Your Quality Management System (QMS)

  An outdated QMS limits growth. Explore how upgrading to an advanced, configurable system like MasterControl can ensure scalability, automation and innovation. 

• How To Overcome Common Single-Use Assembly Design Challenges

  Single-use systems offer major benefits in pharma manufacturing, but design complexity brings challenges. Learn how to overcome issues like scalability and quality assurance with integrated strategies.

• Unlocking Digital Transformation: Embrace CSA For Rapid Innovation

  Gain valuable insights from industry leaders on how life sciences manufacturers can embrace innovation and digital transformation through the FDA’s CSA guidance.

• A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk

  10/10/2024

  Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.

• 5 Trends Impacting CMOs In 2025

  2/4/2025

  In 2025, CMOs will navigate Annex 1 compliance, the BioSecure Act’s uncertainty, AI-driven drug development, supply chain challenges from tariffs, and pandemic preparedness strategies.

• Getting Equipped For The Future With A New Microbial Air Sampler

  8/25/2025

  Discover how a new microbial air sampler meets evolving production demands to enhance compliance, reduce errors, and streamline air monitoring in today’s digital, GMP-regulated environment.

• 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.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  12/9/2024

  21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.