Clinical Quality Assurance Roles and Responsibilities for Auditors and Managers
$1,797.00
Product Details
Clinical trial sponsors rely on clinical quality assurance (CQA) auditors to find vulnerabilities before noncompliance can shut down their studies.
But with millions of dollars and decades of research at stake, study staffers aren’t always eager to cooperate.
That’s why even the most experienced CQA auditors must apply the necessary tools and skills to the CQA function, including how to:
- Understand the basic principles of GCPs and international regulations
- Determine if GCPs are being followed and what needs to be documented
- Balance the relationships — QA, clinical and the CRO — in the ever-changing economy where clinical study outsourcing is common
- Define responsibilities with outsourced clinical trials and the role communication plays in maintaining compliance
- Select sites to be audited — strategies for deciding who to audit
- Audit a CRO or central laboratory — who and how do you audit these specialized providers
- Manage the audits (logistics, time, etc) — understanding the management of the audit is essential to assuring completion of everything that needs to be done
- Conduct the audits — what do you do and what interviewing skills are needed
- Compose the site visit audit report — writing it is sometimes the hardest thing to accomplish
- Evaluate the audit findings and implementing corrective actions — once the report is written the audit is not over
- Master FDA inspections and avoid the top five GCP violations
Who Will Benefit
- Clinical quality assurance managers and auditors
- Clinical site directors
- Clinical research associates/coordinators
- Regulatory affairs
- IRB administrators