In the world of clinical research, a Bioresearch Monitoring (BIMO) inspection isn’t just a routine check-up; it’s a high-stakes evaluation of your data’s integrity and your subjects’ safety. Conducted by the FDA, these audits ensure that the data supporting marketing applications is accurate and that the rights of human participants are protected.

As regulatory scrutiny intensifies, being “inspection ready” must transition from a frantic pre-audit scramble to a continuous state of compliance. This webinar is designed to demystify the BIMO process, moving beyond the “what” of regulations into the “how” of execution. We will explore the common pitfalls that trigger warning letters and provide a strategic roadmap to ensure your site, sponsor organization, or IRB remains beyond reproach.

Topics to be Covered

This session will dive deep into the technical and operational pillars of audit readiness:

• The Anatomy of a BIMO Inspection: Understanding the different types of audits (surveillance vs. directed) and the FDA’s current enforcement priorities for 2026.
• The Golden Rule of Documentation: Mastering ALCOA-C principles (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete) to ensure your Trial Master File (TMF) tells a compliant story.
• Common “Red Flag” Findings: A review of frequent 483 observations, including protocol deviations, inadequate oversight, and IP (Investigational Product) accountability errors.
• The Human Element: How to train your staff for face-to-face interviews with inspectors and managing the “Front Room/Back Room” logistics during the audit.
• Corrective and Preventive Actions (CAPA): How to respond effectively to findings and demonstrate a proactive commitment to quality.
• The Digital Frontier: Navigating the complexities of Part 11 compliance in a world of decentralized trials and eSource.

Why Should You Attend?

The cost of a failed BIMO inspection is staggering—ranging from delayed drug approvals and heavy fines to irreparable reputational damage. This webinar provides more than just theory; it offers actionable intelligence.

1. Reduce Anxiety: Replace the “audit panic” with a structured, confident approach to regulatory visits.
2. Mitigate Risk: Identify “hidden” gaps in your current processes before an inspector does.
3. Stay Current: With the evolution of hybrid and decentralized clinical trials (DCTs), the goalposts for compliance have moved. We’ll show you where they are now.
4. Efficiency: Learn how to streamline your documentation so that readiness is a byproduct of your daily workflow, not an extra burden.

Who Will Benefit?

This session is tailored for professionals across the clinical research spectrum who carry the weight of compliance on their shoulders:

Whether you are a seasoned veteran looking to refresh your knowledge on the latest FDA guidance or a newcomer preparing for your first-ever audit, this webinar will provide the tools necessary to pass your BIMO inspection confidently.