Go Back

Quality Systems Inspection Technique (QSIT), and How to use it to Your Advantage Live Webinar


Location: California, USA
From: 2021/05/06 10:30
To: 2021/05/07 12:00
Posted by: WCS Compliance

About this Event

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

Training Overview

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.

Webinar Takeaway
  • 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 Will Benefit
  • Regulatory Affairs Team Members
  • Quality Departments
  • Compliance Departments
  • Manufacturing Departments
  • Process Engineering Departments
  • Research and Development Departments
  • Design Assurance Departments
  • Top Management
  • Internal Auditors
  • Consultants
Jeff Kasoff (30+ year exp.)

Regulatory Compliance and Quality Assurance ► FDA QSR, ISO 13485/9001 ► Operational Excellence -Remote Consultations

York, Pennsylvania, United States

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.




Save this event

Share with friends:

WCS Compliance

World Compliance Seminars Glorietta Circle

3472825400

Contact the Advertiser

worldcomplianceseminars.com/
Company Details
See other listings from this user


Featured Events


Ercess Inc.
ALERT: KYC/ AML Compliance for Professional Services Firms in the UAE
Why KYC? In this session, the experts discuss KYC/ AML ...
Ercess Inc.
Making your Analytics Strategy Customer Centric
The panel discussion will highlight the challenges and benefits of ...
IHGF Delhi Fair 2021
World’s Premier Sourcing Show’s Awesome 50th edition of IHGF DELHI FAIR ...