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Recorded Webinar
FDA BIMO Inspection: Do's and Don'ts
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
This webinar is intended to provide EQ + practical and actionable guidance on how to proactively prepare for a sustainable FDA BIMO inspection and the proper response, if necessary, during and after the inspection including Do’s and Don’ts.
The United States Food and Drug Administration (FDA) regulates scientific studies, which are designed to develop evidence to support the safety and effectiveness of investigational drugs, biological products and medical devices including in vitro diagnostic devices. Those who are involved in carrying out preclinical studies and clinical studies must comply with the relevant and applicable statutes and regulations, which cover GLP and GCP. This webinar will discuss GLP and GCP in a way to efficiently and effectively help you prepare for an FDA Bioresearch Monitoring (BIMO) inspection. By dissecting the recent ten (10) case studies, you will increase awareness and familiarity for the causes of inspectional deficiencies. You will also be presented with practical and actionable solutions for the same or similar deficiencies. At the end of the webinar, you will get empowered in an effective way that you would plan, develop and execute differently.
The presentation will cover the following areas:
- FDA regulations and guidance on GLP and GCP
- GLP requirements
- GCP requirements
- BIMO program
- BIMO inspection
- How to communicate during and after BIMO inspection
- Clinical investigators (CI)
- Institutional review boards (IRBs)
- Sponsors
- Monitors
- Contract research organizations (CROs)
- ICH-GCP guidelines
- ISO 14155
- Ten (10) case studies
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