Tools and Techniques to Ensure Successful Outcomes in Device GCP Audits

The FDA has implemented stricter regulatory requirements for medical device clinical studies and are now requiring vast amounts of clinical data before a device can be approved for market. Good Clinical Practice (GCP) audits are a critical and complex process that provides device manufacturers with assurance that all parties are operating in compliance with FDA requirements. Audits of clinical SOPs and data can serve as essential preparation for both the manufacturer and clinical investigators prior to a regulatory inspection and provide all stakeholders with greater confidence in the study conduct and research findings. The following presentation will provide attendees with an overview on strategically planning, preparing for and organizing internal and sponsor GCP inspections and specifically cover:

• Various types and levels of auditing structures
• Knowing when to conduct an audit and which teams/personnel to involve
• Defining and incorporating applicable auditing regulatory standards

Attendee Profile
Professionals that would find this recording most beneficial will be those involved in medical device companies with the following job titles:

• Quality Assurance/Systems
• Clinical Affairs & Clinical Operations
• Regulatory
• Compliance