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What Are the Current Tools and Best Techniques for (Clinical Trial) Audit/Inspection Preparedness?

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This webinar on clinical trial audit/ inspection preparedness will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how you can ensure that the conduct of clinical research at the investigative site(s) complies with them.

Speaker
Instructor: Ornat katzir 
Product ID: 702312

Course "What Are the Current Tools and Best Techniques for (Clinical Trial) Audit/Inspection Preparedness?" has been pre-approved by RAPS as eligible for up to 1 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

Significant audit/inspection findings expose you and your organization to regulatory or contractual sanctions, including but not limited to – discontinuation, disqualification, seizure, injunction and/or civil money penalties.

Your position, as a clinical research professional, has an important role in your organization’s preparation for and success at audits/inspections, and it is your responsibility to know how to ensure your organization’s readiness for an audit/inspection at all times.

This training will teach you how to prepare for an audit or inspection and how to act and respond to questions during the audit or inspection. We will discuss in detail about applicable regulatory and sponsor requirements, guidelines and SOPs, and how to ensure the conduct of the clinical research at the investigative site(s) complies with them. By attending this training you will be able to appropriately act upon the audit or inspection findings – to correct current misconduct and prevent future recurrence.

After completion of this training not only will you prepare your organization for audits/inspections but also ensure they are successful.

Learning Objectives:

Areas Covered in the Seminar:

Who Will Benefit:

This webinar will provide valuable assistance to the following Clinical Research Personnel in the Pharma, Biotech and Medical Device industries:

Instructor Profile:

Ornat Katzir, MSc., MHA

Over 15 years of experience in clinical research:

Hands on experience in various aspects of clinical research:

Topic Background:

Performing clinical research is a complicated business, involving multiple projects, participants and cultures, as well as various applicable guidelines and regulatory requirements.

The Sponsor, CRO, Investigative site/Investigator are responsible to conduct the clinical research in accordance with the signed agreements, relevant, current protocol(s) and the applicable regulatory requirements and international as well as local guidelines.

The most acceptable way for the sponsors, CROs, Investigational sites and regulatory authorities to confirm that the clinical research is conducted in compliance with the applicable regulatory, site and sponsor requirements, guidelines and SOPs, is to perform an audit or an inspection of the clinical site.

Audits and inspections follow similar processes with similar outcomes although they are handled differently. Clinical Quality Assurance audits are scheduled in advance whereas regulatory authority inspections might occur without or with a very short prior notice.

In most cases, soon after a Sponsor, CRO, Investigative site/Investigator is notified of a planned Audit/Inspection, intensive and stressful preparation takes place, very often not successfully completed in time for the Audit/Inspection.

Any organization involved in clinical research must be familiar with the current tools and techniques and develop procedures to ensure continuous compliance, consistency and ethical conduct of clinical research as well as minimize risk and maintain quality performance. Such procedures will eliminate the stress and lack of efficacy of last minute preparations for Audits/Inspections.

Follow up on the Audit/Inspection findings must be effective to ensure corrective actions for the deficiencies are implemented and recurrence is avoided. This will enhance future Audit/Inspection preparedness and success.

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Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
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