GUEST COLUMNISTS

• Unlocking Value In Biopharma Operations: A C-Suite Call To Action

  Operational readiness will separate the leaders from the laggards, whether you lead a pharma/biotech innovator, CDMO, or a combination of both.

• Audit Trail Compliance And What To Look For In Mitigation Software

  In the pharma/biotech and medical device industries, the audit trail is important to have for accountability, data integrity, repeatability to create an event for investigation, and regulatory compliance.

• The New Clinical Packaging Paradigm: Differentiation And Decentralization

  The rapid evolution toward flexible, decentralized clinical supply models is placing unprecedented strain on traditional clinical packaging organizations. Can traditional models adapt fast enough to stay viable?

• Process Validation: Optimizing Operational Excellence In Pharma And Medical Devices

  Process validation is often viewed as a costly regulatory formality. However, it is actually a strategic investment that, when integrated into business planning, delivers measurable outcomes in productivity, compliance, speed-to-market, and profitability.

• Cleaning Process Capability: Risk-Based Cleaning Process Performance Qualification

  A cleaning validation professional must know how many process performance qualification runs are necessary. Here's how to go about demonstrating this with a high degree of assurance while minimizing the number of qualification runs.

• AI-Assisted QMS: Bridging ISO/IEC 42001:2023 And ICH Q10 For Pharmaceutical Excellence

  Integrating AI into quality management systems (QMS) can be a transformative opportunity to enhance quality assurance, improve compliance, and enable proactive risk management. 

• Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight

  Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.