How to Survive an FDA Inspection

How to Survive an FDA Inspection
Date
2015-08-03
Organizer
Event contact title
Compliance4all
Event contact first name
Adam
Event contact last name
Fleaming
Email
support@compliance4All.com
Event contact telephone number
18004479407
Fax
302-288-6884
Notes
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 Read more : http://www.compliance4all.com/control/w_product/~product_id=500423LIVE/
Description
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
Attendee information
Principal Investigators Clinical Research Scientists Clinical Research Associates (CRAs) and Coordinators (CRCs) Recruiting Staff QA / QC auditors and Staff Clinical Research Data Managers
Future dates
Monday, August 3, 2015 | 10:00 AM PDT | 01:00 PM EDT | Duration: 90 Minutes

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