Halloran's Inspection Readiness Methodology: Failure To Plan Is A Plan To Fail

By Sheila Gwizdak, Meaghan Marchand, Scott Rettig, and Laura Gilliam

Health Authority inspections can occur anytime during a product’s lifecycle, making thorough preparation crucial for market approval. Unfortunately, sponsors often start preparing only when major milestones, like Biologics License Application (BLA) or New Drug Application (NDA) submissions, are near. This last-minute approach can lead to stress, overwhelmed teams, and avoidable inspection issues, potentially delaying development.

Effective inspection readiness requires more than a checklist; it demands an ongoing commitment to compliance from the start of the development process. Adopting a proactive inspection readiness mindset helps minimize risks and ensures continuous preparedness.

Our upcoming webinar can help you adopt this mindset. Topics include:

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

Moderated by Sheila Gwizdak, Vice President and Head of Consulting at Halloran Consulting Group, the panel includes experts Meaghan Marchand, Scott Rettig, and Laura Gilliam, all from Halloran Consulting Group. They will share their extensive experience and practical tips to help you navigate inspection readiness complexities.

Join us to learn how to stay inspection-ready throughout the clinical trial process and enhance your chances of market approval for your product.