Strategies for Defining a ‘State’ of Inspection Readiness: How Do We Get There? Engaging with Management to Achieve this Goal
Please join SQA at this Symposium presented by leading industry representatives of Sponsors, CROs and Consulting companies to discuss strategies for defining and maintaining a 'State of Inspection Readiness'. Geared toward those leaders who are responsible for the strategy and oversight of inspection readiness, this Symposium will include interactive panels, roundtable discussions and case study presentations to help companies of all sizes with designing and managing these activities. Additional perspective by a FDA representative will add to the conversation as we discuss what our Regulators see as challenges during an Inspection. We hope you can join us in Portland for this event!
Who Should Attend:
- Integrating inspection readiness strategies into your organizational culture
Discussions Will Include:
- Leaders responsible for Inspection Readiness Strategy and Post Inspection Follow-Up
- How do you define your inspection readiness strategies?
- Comparisons on the different regulatory agency expectations during an inspection
- Resourcing challenge to be ‘inspection ready’
- Provide practical examples that can applied to any inspection readiness plan
- Developing strategies using risk tolerance methods
- Senior Leadership Culture in supporting inspection readiness activities
- Managing the post-inspection activities
- Prevention vs Prediction vs Mitigation
- Issues related to risk management in a regulated environment (GLPs vs GCP vs GMP)
- How does company size impact your inspection readiness?