Can your organization survive a Food and Drug Administration (FDA) inspection? Are you aware of the different aspects of your business that the FDA will be inspecting? This course, “FDA’s Quality System Inspection Technique (QSIT),” is intended to facilitate manufacturer compliance with the FDA’s Quality System Regulation (QSR) and related regulations, and increase inspection consistency, product quality, and the efficiency of the enforcement action review process.
This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management, who need to understand the methodologies used by FDA during inspections. During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used by the FDA is clearly of high importance.
The overwhelming majority of field inspections performed by FDA inspectors are done according to the QSIT. It is thus imperative that all regulated companies have an in-depth knowledge of this system, to enable them to prepare for the inspection. Delving into each and every section of the QSIT, this webinar also includes a helpful method for incorporating it into your company’s ongoing quality system.
- Understanding the purpose, benefits and objectives of FDA’s QSIT
- How to Plan and prepare for your FDA inspection
- Identifying what inspectors look for during a QSIT inspection
- Understanding FDA’s statutory authority
- In depth analysis of the 4 major subsystems
- Reviewing of remaining subsystems
- Managing inspection process
- Following up after an inspection
- Understanding FDA enforcement actions
- Knowing how to utilize the QSIT approach in internal auditing
- Regulatory Affairs Team Members
- Quality Departments
- Compliance Departments
- Manufacturing Departments
- Process Engineering Departments
- Research and Development Departments
- Design Assurance Departments
- Top Management
- Internal Auditors