INSIGHTS ON QUALITY ASSURANCE

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  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.

• Maximizing ROI: Extracting Value From Analysis And Reporting

  How can organizations establish the foundation for advanced analytics, AI and ML, in pursuit of a robust and adaptive lab of the future?

• Combine Product And Process Insight With An Integrated Digital Backbone

  Learn how you can make strategic decisions faster by harnessing the power of data you generate through a digital data backbone.

• Getting CMC Right For Emerging Technologies

  Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

• Regulatory Considerations Including Extractables & Leachables For Single-Use Manufacturing

  10/29/2024

  Watch to gain insights into regulatory guidance for single-use manufacturing and risk assessment strategies for single-use implementation.

• Contamination Control Strategy With QRM Principles

  11/19/2024

  Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

• Development Of Separation Methods For GLP-1 Synthetic Peptides

  6/30/2025

  Explore a novel HPLC-UV/MS method for analyzing GLP-1 analogs to address critical challenges in peptide separation, impurity detection, and performance for improved reproducibility.

• Automated Active Microbial Collection In Aseptic Filling Lines

  9/21/2025

  Learn how automated environmental monitoring strengthens contamination control strategies, reduces risk, and supports intervention planning in aseptic filling lines.

• The Role Of CDMOs In Supporting Generic Drug Development

  7/15/2025

  Bringing complex generics to market requires deep expertise. Learn how a CDMO can help navigate regulatory, technical, and commercial challenges with end-to-end development and manufacturing support.