WEBINAR OVERVIEW

When it comes to quality system audits, the level of preparation within your organization can make a significant difference in your level of success. This webinar discusses how to effectively prepare for and manage an FDA inspection.

I. Audit Preparation - Actions taken before the audit, including Audit Procedure, the Information Book and Team Preparedness
II. Audit Execution - Inspection operations, the Control and Audit Rooms, Interacting with the FDA
III. Audit Remediation - Documentation and audit responses, taking the necessary corrective and/or preventive actions

LEARNING OBJECTIVES

The following topics will be discussed:

• The Role of Organizational Culture
• Developing an Audit Procedure
• Preparing the Information Book
• Defining Staff Roles and Responsibilities
• Team Preparedness
• The Control and Audit Rooms
• Inspection Procedures/What to Expect
• Interacting with the FDA
• Documentation and Remediation

AUDIENCE

This course is appropriate for the following individuals:

• Facilitators
• Scribes & Runners
• Subject Matter Experts
• Control Room Staff
• Quality Staff
• Management Team

ABOUT THE SPEAKER

Mr. Larry Mager, Vice President of Quality and Compliance, has over 15 years of experience in the life science industry. Larry has held responsible positions within medical device manufacturing companies ranging from start-ups to large corporate organizations. He has executed senior management responsibilities and coached teams in both Quality Management and Operations Management roles, and brings an intimate understanding of third-party audits and quality system management.