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Recorded Webinar
FDA Case Scenarios – Best Practices for Managing Inspection Situations
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
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.
This presentation will provide great opportunities to become familiar with the FDA inspection policy and industry’s best GMP practices including the lessons learned from the most common deficiencies observed during the FDA inspections of firms (devices and pharmaceuticals) for the past eight years.
Learning Objectives
- Which FDA sanctions apply to you, and how to operate in compliance with FDA requirements.
- What to do when FDA knocks – step by step instructions to handle inspections.
- How to handle day by day inspection scenarios?
- What is a front room and back room? Do you need one?
- Runners and Scribes? What do they do?
- Are your SME’s the right people, and are they ready/right for the job?
- Why responses to 483’s and Warning Letters are critical?
- Steps for responding to 483’s and Warning Letters
Session Highlights
- What to expect during an FDA inspection
- Applicable Laws and Regulations
- FDA Manuals and Inspection Guides
- Inspection Types and Categories
- Inspection Classification
- FDA Forms 482 and 483
- Recent Trends
- Real-life scenarios and how to properly respond
- Tips for a successful audit
- Inspection Preparation Procedures
- Speaker’s PASS-IT Recommendations
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