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

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:

• Understand what Audits/Inspections are all about.
• Obtain tools and techniques for a planned Audit/Inspection preparation.
• Learn the DOs and DON'Ts prior to and during an Audit or Inspection.
• Understand what actions are required following an Audit/Inspection.
• Obtain tools and techniques to ensure Audit/Inspection preparedness is maintained at all times.

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 sponsor, CRO, Investigational site/Investigator.
• Preparation for a planned Audit/Inspection – tools and techniques.
• 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.
• Implementation of corrective action plan – tools and techniques.
• Ensuring continuous Audit/Inspection preparedness – tools and techniques.

Who Will Benefit:

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

• Sponsor/CRO/Investigative sites General Managers and Directors
• Principal Investigators
• Site Coordinators
• Project Managers
• Clinical Team Managers/Leaders
• Clinical Research Associates / Monitors
• Project Assistants
• Clinical Research Trainers
• Quality Assurance personnel
• Regulatory Compliance Associates and Managers

Instructor Profile:

Ornat Katzir, MSc., MHA

Over 15 years of experience in clinical research:

• CRA and GCP manager in a US international pharmaceutical company
• Sr.CRA, Principal CRA, Team manager and The Israeli Associate Clinical Operations manager of a large global CRO headquartered in the US
• Quality Management Systems Associate of a large global CRO headquartered in the US
• Independent Clinical Research Consultant, GCP auditor and trainer

Hands on experience in various aspects of clinical research:

• Monitoring and management of all stages of clinical research
• Development, review and assessment of clinical research documents and tools (Protocols, Informed Consent Forms, Case Report Forms, Questionnaires etc.) for compliance with applicable standards and regulations
• Development, review and assessment of internal systems/processes, standard operating procedures and working practice documents for compliance with applicable standards and regulations
• Systems and process audits and development of methodology and tools for these audits/reviews
• Development and quality check of documents summarizing the requirements for clinical trials in specific regions/countries
• Conduct of sponsors, CROs, sites and vendors GCP Audits
• Training clinical research personnel (sponsor/CRO and research sites teams)

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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