FDA Case Scenarios – Best Practices for Managing Inspection Situations
🎤 Danielle DeLucy | 📅 Recording Available | 🕒 11 AM Eastern Time US
  | Every year or so, companies are visited by the FDA and other regulators to determine if they are properly complying with regulations. Once the inspectors arrive, there may be times that situations arise that are difficult to respond to. In this webinar, we will analyze how certain situations were handled and how they could have been handled differently, or what was positive about how they were handled. |
Description:
Companies can prepare and train their staffs effectively for prior inspection management, but once the audit begins, certain difficult situations, requests or issues may arise that may prove hard to manage properly. In this webinar, you will hear about real life examples of inspection issues on different topics such as Opening Day, Documentation, Tours, SME situations, Safety and Inspection team situations. We will examine what went right and how the situation may have been handled differently.
Areas Covered in the Session :
- What to expect during an FDA inspection
- Real-life scenarios and how to properly respond
- Analysis of different Case Studies
- Managing difficult situations
- Tips for a successful audit
- Interactive Q&A Session
Who Will Benefit:
- Site Quality Operations Managers
- Quality Assurance Departments
- Plant Managers and Supervisors
- Manufacturing Departments
- Regulatory Affairs Departments
- Individuals whose job knowledge and/or expertise may be called upon during an audit
