Responding to an Audit Report
Preparation of a Concise Response to an Audit Report
Duration: 2 CPD Hours
Course description:
This course is designed both for those that currently work in the health care industry across organisations (Pharmaceutical/Biotech/CRO's/Investigator Sites) and require training in responding to an Audit Report which has been issued by the Medical/Clinical QA Departments, the course is also designed for those that have none or very little experience in the field of Clinical Research (BSc or Post Graduate Certification required- nursing or science) and want to gain an understanding of Compliance within the health care industry. This course provides training and an indepth insight to those that would like to work in the area of Clinical Compliance in a Pharmaceutical/Biotech/Contract Research Organisations or Investigator Sites (Hospital Based)
Elements covered in this course:
- Why are Audits Necessary
- What are the Key Questions Raised
- Who are the Key Contributors
- Establishing a Root Cause
- Corrective Preventative Action Plan
- Detailed Audit Responses
- What is an Acceptable Response
- A Checklist for Audit Responses
- Levels of Observations in Audits
- Example of Corrective Action Plan
- Example of Preventative Action Plan
more....
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