Click to join or renew
ISPE Logo - Click to go to the ISPE home page

eLearning


Search

for

Log in
Name: Inspection Readiness Overview with Interview Techniques ( WEBINSPECT )
Description: Preparing for an inspection by FDA or other regulatory authorities requires the resources and interaction of every department in your company. You and every member of your team can benefit by becoming acquainted with the overall inspection readiness process and preparing for the potential of being interviewed by an auditor. This instructive and useful webinar provides an overview of the inspection readiness process, from internal evaluation of your quality systems to the logistics of the audit itself, with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.
Objectives: At the conclusion of this session, participants will be able to:
  • Understand the tools needed to accomplish tasks related to inspection readiness
  • Describe regulatory authorities' audit processes
  • Effectively fulfill your role and responsibility during an audit
  • Use techniques to establish yourself as an expert in your functional area
  • Use techniques to formulate responses to various types of questioning used by FDA and other regulators
  • Apply strategies for guiding auditors to your quality system's strengths instead of weaknesses
  • URL:
    CEUs: .15
    Member Price: US Dollar        EURO
    Non Member Price: US Dollar        EURO
    Instructors:
    Copyright 1997- International Society for Pharmaceutical Engineering   |   Privacy Policy   |   Terms of Use