INSIGHTS ON REGULATORY COMPLIANCE

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.

• X-Ray Inspection For Supplement Safety

  Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.

• Understanding cGMPs For Phase 1 Investigational Drugs

  Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.

• Prioritizing Data Security Through Digital Transformation

  Integrating advanced digitalization solutions and prioritizing data security can accelerate drug development while reducing costs and ensuring consistency across a global network.

• Navigating The Paradigm Shift: Ensuring Efficacy In Risk-Based Cleaning Validation

  10/23/2024

  Unearth how adopting a risk-based approach to cleaning validation can enhance product quality, safety, and regulatory compliance in pharmaceutical manufacturing.

• Scientific Insights Into VHP Biodecontamination And BI Quality Management

  9/24/2025

  VHP biodecontamination ensures aseptic manufacturing, but BI variability challenges validation. Addressing rogue BIs and regulatory shifts strengthens contamination control and process reliability.

• Advances In Regulations For Viable Environmental Monitoring

  2/21/2025

  Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

• ICH Q12 Implementation: Regulatory Intelligence And PACM Agility

  7/9/2024

  Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.

• Biomanufacturing Operator Training And Solutions

  5/20/2025

  Discover a hands-on biomanufacturing training program that empowers operators with essential skills, boosts efficiency, and supports innovation in the fast-paced biopharma industry.