Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules 2015 2026 2027 (55627)

Ways to train employees in view of the inspection
How a firm should prepare for an FDA inspection
How to interact with the investigator-DO`s and DON`T`s
How to ensure that required documentation is in place
How to reply to 483`s and warning letters
What companies should do when the inspection ends
Post inspection actions
Legal implications of non-compliance
The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents
Why inspections are conducted and by what statutory authority
Understand and apply the do`s and don`ts and comprehend that preparation is the key to success
What is subject to FDA purview and what`s off-limits
What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key
What are the prohibited "Acts" and the enforcement categories that you need to deal with
How to respond to findings and facilitating the documentation and remediation process...and reaching final closure
The company`s Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel
Define clear responsibilities, roles and goals for personnel involved in SOP development

Attendees from regulated companies that are preparing for FDA inspections, including:

Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules 2015