Even well-trained staff can face difficult situations once an FDA inspection begins. This 60-minute FDA inspection management webinar uses real-life examples to show how tricky requests and issues were handled, what went right and what could have been done differently.
Scenarios cover opening day, documentation, facility tours, subject matter expert situations, safety and inspection team issues. You'll also review what to expect during an inspection, from the opening meeting through daily close-outs to the final meeting.
The session covers how to handle difficult questioning, how to interact with inspectors, and how to organize inspection rooms and teams and deliver the right pre-audit training.
WHY SHOULD YOU ATTEND?
FDA and other regulators visit companies regularly to check compliance, and once inspectors arrive some situations are hard to respond to. Seeing how real cases played out helps you prepare your own team.
The session suits site quality operations managers, QA personnel, plant managers and supervisors, manufacturing superintendents and managers, regulatory affairs managers and anyone whose expertise may be called on during an audit.
AREA COVERED
- What to expect during an FDA inspection
- The opening meeting, daily close-out and final meeting
- Real-life scenarios: opening day, documentation, tours, SME situations, safety and inspection team issues
- How the scenarios were handled and what resulted
- Handling difficult questioning and interacting with inspectors
- Organizing inspection rooms and teams
- Pre-audit training
- Tips for a successful audit
LEARNING OBJECTIVES
- Describe what happens during an FDA inspection from opening to final meeting
- Respond properly to difficult situations and requests
- Handle difficult questioning and interact professionally with inspectors
- Organize inspection rooms, teams and pre-audit training
- Apply lessons from real inspection scenarios
WHO WILL BENEFIT?
- Site Quality Operations Managers
- Quality Assurance personnel
- Plant Managers and Supervisors
- Manufacturing Superintendents and Managers
- Individuals whose job knowledge and/or expertise may be called upon during an audit
- Regulatory Affairs Managers
FDA and other regulators visit companies regularly to check compliance, and once inspectors arrive some situations are hard to respond to. Seeing how real cases played out helps you prepare your own team.
The session suits site quality operations managers, QA personnel, plant managers and supervisors, manufacturing superintendents and managers, regulatory affairs managers and anyone whose expertise may be called on during an audit.
- What to expect during an FDA inspection
- The opening meeting, daily close-out and final meeting
- Real-life scenarios: opening day, documentation, tours, SME situations, safety and inspection team issues
- How the scenarios were handled and what resulted
- Handling difficult questioning and interacting with inspectors
- Organizing inspection rooms and teams
- Pre-audit training
- Tips for a successful audit
- Describe what happens during an FDA inspection from opening to final meeting
- Respond properly to difficult situations and requests
- Handle difficult questioning and interact professionally with inspectors
- Organize inspection rooms, teams and pre-audit training
- Apply lessons from real inspection scenarios
- Site Quality Operations Managers
- Quality Assurance personnel
- Plant Managers and Supervisors
- Manufacturing Superintendents and Managers
- Individuals whose job knowledge and/or expertise may be called upon during an audit
- Regulatory Affairs Managers