How to Survive an FDA Inspection
Bioresearch monitoring program or BIMO is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research
The BIMO program monitors:
Why should you Attend:
- Sponsors/Contract Research Organizations (CROs)/Monitors
- Institutional Review Boards (IRBs)
- Clinical Investigators (CIs)
- Nonclinical Laboratories
BIMO Program Objectives are to Protect the rights, safety, and welfare of human research subjects and Assure the quality, reliability, and integrity of data collected.
BIMO Program Functions are to Audit clinical data, Inspect ongoing clinical research, Inspect nonclinical laboratories, Inspect IRBs, Educate and train and Implement FDA's Application Integrity Policy.
What may Prompt an Inspection of Research may be New Product or Indication, New Technology, Complaints, History of non-compliance, and Routine Surveillance.
Areas Covered in the Session:
Who Will Benefit:
- Causes of audits
- What is necessary to prepare
- How to act during audit
- How to resolve audit findings
- Principal Investigators
- Clinical Research Scientists
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting Staff
- QA / QC auditors and Staff
- Clinical Research Data Managers