INSIGHTS ON QUALITY CONTROL

• Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance

  Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.

• Leveraging A Modern HPLC System For Peptide Drug Substances Analysis

  This study assesses a modern HPLC system within a routine QC testing environment focused on peptide-size biopharmaceuticals.

• Tackling Residual DNA Testing In Biotherapy Manufacturing

  Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.

• Data Integrity In The Quality Control Lab: No Pen, No Pain

  Data integrity in pharmaceutical QC labs is critical for product safety. This webinar explores digital solutions to improve traceability, reduce paperwork, and enhance workflows.

• A New Framework For Identifying Nitrosamine Risks And Derisking Products

  6/18/2024

  Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

• Characterizing The Physical Properties Of Spray Dried Powders

  10/21/2024

  Ensure the success of your spray-dried powder formulations by thoroughly assessing their physical properties early in the development process to optimize handling, stability, and performance in final dosage forms.

• Method Migration Of A Normal Phase HPLC Method For Tocopherols

  9/17/2024

  The ability to migrate methods across HPLC systems is essential as systems are updated. Review a normal phase method that provides a means for quantification of tocopherols in vitamin supplements.

• EMPQ And Validation Support Services

  2/21/2024

  A growing pharmaceutical/biotech company hired a global consulting firm for a project that required EMPQ services for qualification activities on a newly completed aseptic processing suite.

• CDMO Audit Coverage: Key Focus Areas And Compliance Objectives

  12/30/2025

  CDMO audits focus on compliance, quality, performance, and relationships to reduce risk, ensure clear documentation, and align customer expectations with CDMO capabilities.