The Quality Systems Investigation Technique (QSIT) is an inspectional process used to assess a medical device manufacturer
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 seminar:
- 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.
Who will 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
Instructor Profile:
Jeff Kasoff, RAC, is
the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of
consumables and instrumentation in the urodynamic and pain management fields.
Jeff is responsible for oversight of corporate compliance with domestic and
international regulations, preparation of submissions, and is primary liaison
with regulatory agencies and notified bodies. Jeff began his regulatory career
as the first full-time employee of Optex Biomedical, a device start-up, where he
initiated their regulatory policies and procedures and prepared their
submissions. Jeff received his Regulatory Affairs Certification in
1996.
