FDA Inspection 2015 - How to Survive an FDA Inspection

Overview:
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:
Sponsors/Contract Research Organizations (CROs)/Monitors
Institutional Review Boards (IRBs)
Clinical Investigators (CIs)
Nonclinical Laboratories
Why should you Attend: 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:
Causes of audits
What is necessary to prepare
How to act during audit
How to resolve audit findings
Compliance4All
Adam Fleaming
Phone: +1-800-447-9407
Event Link: www.compliance4all.com/control/w_product/~product_id=500432LIVE
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