Virtually all 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 straightforward, helpful methods for incorporating it into your companyâ€™s ongoing quality system.
Areas Covered in the Session:
- 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