How to Survive an FDA Inspection
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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
Omid Khodai OD, MS, RAC, CQA, CQM/OE, has more than 16 years of experience in Clinical, Medical, and Regulatory Affairs in senior management roles.
He has coordinated all strategic and tactical aspects of regulatory submissions and clinical studies/trials according to standard operating procedures, study protocols, and domestic and international regulatory guidelines. Speaker has skillfully led the development and delivery of products across diverse therapeutic and diagnostic areas.
Prior to being a consultant, he served as Director of Clinical Research at Boston Scientific. In this role he led the clinical team to design and execute the company’s clinical trial strategy to produce a clinical evidence-base for regulatory, reimbursement, and commercial positions. He also served as Global Head of Clinical and Medical Affairs at STAAR Surgical, including successful approval of FDA Advisory Committee.
He also served as Executive Director of Clinical and Medical Affairs and Scientific Communication at Bausch and Lomb where he successfully led the organization to approval of FDA Advisory Committee and commercialization of first of kind product as well as successful integration of a $5 Billion business through acquisition.