FDA Case Scenarios - Best Practices for Managing Inspection Situations

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.

• 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

• 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

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.

• 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

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.