Inspection Readiness Methodology: Failure to Plan is a Plan to Fail

Watch Halloran’s Inspection Readiness Webinar Here

A Health Authority inspection of a clinical trial can occur at any point during a product’s lifecycle, making adequate preparation essential for a successful inspection and eventual market approval. Unfortunately, sponsors often begin preparing for inspections only when a critical milestone, such as a Biologics License Application (BLA) or New Drug Application (NDA) submission, is imminent. This last-minute approach can lead to stress, overwhelmed teams, and avoidable inspection findings, which may delay development milestones.

Effective inspection readiness goes beyond completing a checklist. Sponsors must embrace an inspection readiness mindset early in the development process by establishing and maintaining an ongoing, efficient system for compliance and preparedness. This proactive approach minimizes risks and ensures that the organization is always prepared for an inspection.

If you are seeking to adopt this mindset and enhance your inspection readiness, our upcoming webinar offers valuable insights. The session will cover:

• Ideal inspection readiness timelines and scenarios
• Key dos and don’ts during inspections
• Practical recommendations for inspection preparation
• Common trends observed in Form 483 observations and warning letters

Our expert panel includes Sheila Gwizdak, Vice President and Head of Consulting at Halloran Consulting Group, who will serve as the moderator. The speakers are Meaghan Marchand, Senior Specialist; Scott Rettig, Senior Specialist; and Laura Gilliam, Specialist, all from Halloran Consulting Group. They will share their extensive experience and practical tips to help you navigate the complexities of inspection readiness.

Join us to gain a deeper understanding of how to stay inspection ready throughout the clinical trial process and learn strategies to ensure your team is always prepared for an inspection, thereby enhancing the likelihood of achieving market approval for your product.