Compliance Confidence: Strategies for a Successful Regulatory Inspection
The primary purpose of this program is to develop Compliance Confidence by showing proper regulatory inspection preparation and response techniques. The program consists of a six scenarios that depict employees who are unsure of how to best handle themselves. The scenarios are designed to help employees think about:
"How can I be better prepared for a regulatory inspection”
“How could I have done things differently when responding to the inspector?”
At the end of this program, participants will be able to:
- Identify key components of how the Audit/Inspection preparation room should be set up and organized.
- Describe how documents are to be handled with an inspector.
- Describe the proper response when encountering a spill in a hallway.
- Identify issues related to laboratory mistakes.
- Describe the relationship between visitors and SOPs.
- Identify 3 key guidelines to follow when interviewed by a regulatory inspector.
- Leader's Guide
- Video Script
- Discussion Guide and Answer Key
- Assessment and Answer Key