FDA Case Scenarios – Best Practices for Managing Inspection Situations

Product Id : FDA157
Instructor : Danielle DeLucy
Sep 05, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Why is FDA at my facility, and what do I do during an inspection?

Preparing for successful inspections is not a one-time event. Being inspection ready means that pharmaceutical leaders are committed to managing compliance as part of their company culture. Industry experts say successfully managing compliance is something that is done every day and not something done to prepare for an inspection by Food and Drug Administration regulators.

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.

Why Should You Attend:

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

If you are looking for answer of these questions, you would certainly benefit by attending this webinar:

  • 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

Who Will Benefit:

  • Site Quality Operations Managers
  • Quality Assurance Personnel
  • Plant Managers and Supervisors
  • Manufacturing Superintendents and Managers
  • Regulatory Affairs Managers
  • Individuals whose job knowledge and/or expertise may be called upon during an audit
Speaker Profile:

Danielle DeLucy,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.

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