There is a continuous shift in the emphasis from FDA for the FDA cGMP compliance inspection or audits as per 21 CFR 210/211 &820. The focus has a major impact on the individual compliance objectives which companies need to understand, focus their efforts and align the measurement parameters.
If companies can understand what can be expected in the weeks before the site visit, during the inspection, and post-inspection actions and give proper responses, timelines, and expected documentation, they can get saved from adverse impact, 483s, warning letters. It is key to understand across various areas what exactly FDA inspectors are being asked to look for.
This webinar will evaluate the key areas of an FDA CGMP compliance inspection / audit objective to see actual and anticipated changes in emphasis. QSIT for medical devices and pharmaceutical requirements will be discussed. Training will cover virtual audit and layered process audit strategies as well.
Approximate Duration 50 minutes.
Cost : 
: Limited Period Offer
Package contains : E-learning Video file in mp4 format
Areas covered:
- Basic U.S. FDA’s expectations – the focus of QSIT on the sub systems
- What is the first thing to do when thinking about upcoming FDA inspection
- Drug Audit elements – CFR 210/211
- Device Audit elements – CFR 820
- Major Industry problem areas 25+ collected from various actual inspections Observations related to P & PC, cGMP training, Complaint handling, labeling, lab controls
- What to expect before, during and after a US FDA CGMP inspection
- Important and required post-inspection actions
- QMS issues, documentation requirements
- How to establish the test procedures
- US FDA QSIT Model and 4 key sub-systems explained. (management control, Design control, CAPA, P & PC )
- Things to avoid during and after inspection
- Layer Process Audits and best practices
- Virtual Audits and how to execute it.
Price :
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