INSIGHTS ON REGULATORY COMPLIANCE

• Performance Dashboards Development

  Learn about a biotech company's successful implementation of a two-level KPI dashboard system. This enhanced performance monitoring, aligned departmental goals, and strengthened team communication.

• Take Action On PFAS To Protect Your Critical Processes

  PFAS restrictions are tightening, but a full ban could disrupt critical industries lacking alternatives, such as pharmaceutical manufacturing. Learn where PFAS use remains indispensable.

• How Compounding Pharmacies Are Combating FDA Drug Shortages

  Explore the global impact of pharmacy compounding, which plays a critical role in mitigating drug shortages and providing personalized medication solutions when commercial drugs are unavailable.

• PUPSIT As Part Of A Contamination Control Strategy (CCS)

  Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

• Uncovering Blind Spots In Environmental Monitoring

  6/19/2025

  Discover how modern strategies like the Contamination Control Strategy are transforming environmental monitoring by exposing hidden risks, enhancing data quality, and unlocking deeper insights through innovative microbial methods.

• Improving Bioprocess Monitoring And Control With Multivariate Data Analysis

  12/9/2024

  Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.

• Qualicaps Virtual Pharma Expo September 2025: Oral Solid Dose Manufacturing And Packaging

  9/18/2025

  Explore how a new capsule inspection system helps manufacturers overcome labor shortages, increase throughput, and maintain quality while meeting global compliance standards.

• Essential Drug Delivery Outputs For Devices To Deliver Drugs, Biologics

  5/16/2025

  All future submissions are expected to align with FDA's draft guidance that clarifies the agency's expectations for establishing, evaluating, and controlling Essential Drug Delivery Output (EDDO) requirements.

• Analytical Strategies For Impurity Control In Antibody-Drug Conjugates

  7/16/2025

  Antibody-drug conjugates (ADCs) combine antibody targeting with potent cytotoxic payloads to treat resistant cancers, but their complexity requires phase-appropriate analytical strategies.