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.
Areas Covered in the Session :
- 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
Who Should Attend:
- Regulatory Affairs Team Members
- Quality Departments
- Compliance Departments
- Manufacturing Departments
- Process Engineering Departments
- Research and Development Departments
- Design Assurance Departments
- Top Management
- Internal Auditors
Course Director: JEFF KASOFF
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.
Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.