Overview: 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 company’s ongoing quality system.
Why you should attend: If you don`t know what the FDA inspector is going to look at when (s)he performs his/her audit, how can you really know what to prepare for? Even a thorough internal audit may not focus on the areas that the FDA inspector will. The most effective way to increase the likelihood of your internal audits identifying issues that the inspector will see is to arrange your internal audit scheme to mimic the process the FDA inspector will use. If you perform your internal audits this way, you`ll be well prepared for the FDA.
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 of high importance. This Webinar provides such an understanding. It will also benefit:
- Top Management
- Regulatory Management
- Quality Management
- Internal Auditors
- Consultants
