Get guided on what is FDA's QSIT, how to prepare for FDA inspection and how to manage your inspection process. Register for the webinar today.

1. Quality Systems InspectionTechnique (QSIT) and How to
use it toYour Advantage
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

2. Instructor Profile:
• Jeff Kasoff, RAC, CMQ/OE 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 Kasoff
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

3. Description:
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
InspectionTechnique (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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

4. Objectives of the Presentation:
• Understand the purpose, benefits and
objectives of FDA's QSIT
• Plan and prepare for your FDA inspection
• Understand FDA's statutory authority
• Manage your inspection process
• Follow up after your inspection
• Understand FDA enforcement actions
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

5. Areas Covered:
• History of FDA inspection methodologies, from
haphazard to QSIT
• Anticipate and prepare for FDA inspection
• Identify what inspectors look for during a QSIT
inspection
• In depth analysis of the 4 major subsystems
• Review of remaining subsystems
• Knowing how to utilize the QSIT approach in
internal auditing
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

6. Who can Benefit:
• 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.This webinar provides
just such an understanding. It will also benefit:
• Top Management
• Regulatory Management
• Quality Management
• Internal Auditors
• Consultants
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

7. Track this Link:
Quality Systems InspectionTechnique
(QSIT)
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com