What Are the Current Tools and Best Techniques for (Clinical Trial) Audit/Inspection Preparedness? 2012

Topics

• Clinical Site Audits/Inspections findings and FDA warning letters
• Audits and Inspections: Definitions, Goals, Causes and Procedures
• Preparation for a planned Audit/Inspection – tools and techniques
• Responsibilities of the sponsor, CRO, Investigational site/Investigator
• Completion and follow up after the Audit/inspection
• Appropriate conduct during the Audit/Inspection
• Implementation of corrective action plan – tools and techniques
• DOs and DON`Ts prior to, during and after an Audit/Inspection
• Ensuring continuous Audit/Inspection preparedness – tools and techniques

Who should Attend

Clinical Research Personnel in the Biotech, Pharma and Medical Device industries, including:

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