A Health Authority inspection of a clinical trial can occur at any time during a product’s lifecycle. Adequate preparation is essential to better position an organization for a successful inspection with the goal of market approval.
Too often, we observe sponsors tackling inspection preparedness right before a key milestone, such as Biologics License Application (BLA) or New Drug Application (NDA) submissions. However, this approach often results in stress, overwhelmed teams, and avoidable inspection findings, potentially delaying development milestones.
Being inspection ready is more than just a checklist. Rather, sponsors must adopt an inspection readiness mindset earlyn on through establishing an ongoing efficient process to maintain compliance and guarantee preparedness. If this resonates, you also may be wondering, ‘what does this mindset look like?
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