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

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.

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.

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