INSIGHTS ON REGULATORY COMPLIANCE

• Compliance Audits: 4 Solutions To Avoid Failure

  Although inspection and audit processes have evolved, you can still effectively navigate and manage them within your organization. Explore four solutions to address audit and inspection pain points.

• 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.

• Validation Of A Sterilization Process: Part 1

  Gain essential insights into sterilization by exploring microbial inactivation kinetics, bacterial spore resistance, and key terminology—critical knowledge for ensuring product safety and compliance.

• ICH Quality Risk Management Guidelines For Biopharma Manufacturing

  Explore the key changes to the ICH Quality Risk Management guidelines that aim to optimize efficiency, effectiveness, and scientifically grounded control strategies.

• Building A Connected Quality And Manufacturing Ecosystem In Life Sciences

  12/27/2024

  Discover the transformative power of connected quality and manufacturing systems, offering strategies for digital transformation, enhanced efficiency, compliance, and real-world success in life sciences.

• Early Development Considerations For Late-Stage NCE Success – Part One

  12/8/2023

  Navigating NCE development can be daunting. Learn about the importance of assessing and mitigating risk at every stage of development and ensure that your NCE has the maximum potential for success.

• The Shift To GMP-Compliant Automation In CGT Manufacturing

  10/6/2025

  Manual processes are yielding to automated, GMP-compliant closed systems in CGT manufacturing. This shift is crucial for meeting Annex 1 contamination standards and creating scalable, reliable commercial production.

• Advancing Cell Therapy Manufacturing: Rapid Sterility Testing

  5/7/2024

  The rapid sterility test kit used in the study was able to quickly detect bacteria and fungi in complex cell therapy product matrices, detecting six species listed in USP chapter <71>.

• Managing Risks In Injectable Drug Delivery

  3/13/2025

  Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.