This webinar on clinical site audit/inspection will outline the responsibilities of the Investigator and the clinical research coordinator during and after site audits/inspections and show what you must do to ensure preparedness at all times.
In order to ensure audit/inspection preparedness, the CRC must be aware of the applicable regulatory and sponsor requirements, guidelines and SOPs, and ensure the conduct of the clinical research at the site complies with them. The site coordinator must know how to prepare for an audit or inspection and how to act and respond to questions during the audit or inspection. Following the audit or inspection, the site coordinator should be able to appropriately act upon the audit or inspection findings.
This 60-minute presentation will detail the responsibilities of the Investigator and the clinical research coordinator during and after Site Audits/Inspections. We will discuss how you can prepare your clinical site for audits/inspections and ensure readiness at all times. This webinar will provide valuable assistance to the Clinical Research Personnel in the Pharmaceutical, Biotech and Medical Device industries.
Why Should You Attend:
The Clinical Research Coordinator (CRC) plays a key role in the site’s success at audits/inspections, and must therefore know how to ensure the site is ready for an audit or inspection at all times.In order to ensure audit/inspection preparedness, the CRC must be aware of the applicable regulatory and sponsor requirements, guidelines and SOPs, and ensure the conduct of the clinical research at the site complies with them. The site coordinator must know how to prepare for an audit or inspection and how to act and respond to questions during the audit or inspection. Following the audit or inspection, the site coordinator should be able to appropriately act upon the audit or inspection findings.
This 60-minute presentation will detail the responsibilities of the Investigator and the clinical research coordinator during and after Site Audits/Inspections. We will discuss how you can prepare your clinical site for audits/inspections and ensure readiness at all times. This webinar will provide valuable assistance to the Clinical Research Personnel in the Pharmaceutical, Biotech and Medical Device industries.
Learning Objectives:
- Understand what Audits/Inspections are all about.
- Learn how to ensure Audit/Inspection readiness are maintained at all times.
- Learn how to prepare for a planned Audit/Inspection.
- Become familiar with the DOs and DON'Ts prior and during an Audit or Inspection.
- Understand what actions are required following an Audit/Inspection.
Areas Covered in the Seminar:
- Audits and Inspections: Definitions, Goals, Causes and Procedures.
- Clinical Site Audits/Inspections findings and FDA warning letters.
- Responsibilities of the Investigator and the clinical research coordinator
- Keeping site's continuous Audit/Inspection preparedness.
- Preparation for a planned Audit/Inspection.
- Appropriate conduct during the Audit/Inspection.
- Completion and follow up after the Audit/inspection.
- DOs and DON'Ts prior to, during and after an Audit/Inspection.
Who Will Benefit:
This webinar will provide valuable assistance to the following Clinical Research Personnel in the Pharma, Biotech and Medical Device industries:- Clinical Research/Site Coordinators
- Clinical Research Investigators
- Clinical Research Associates/Monitors
- Clinical Research/Project Assistants
- Clinical Research Trainers
- Clinical Team managers
- Regulatory Compliance Associates and Managers
Course Provider
Ornat katzir,
