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FDA Case Scenarios - Best Practices for Managing Inspection Situations

  • By: Danielle DeLucy
  • Recorded Session
  • Duration: 60 Minutes
  • Training Level: Intermediate to Advanced
  • Email Reminder

Transcript

Recorded Session

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Training CD

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Webinar Details

OVERVIEW

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.

LEARNING OBJECTIVES

  • What to expect during an FDA inspection
  • The opening meeting, daily close out and final meeting
  • Real-life scenarios and how to properly respond
  • Tips for a successful audit
  • How to handle difficult questioning, how to properly interact with the inspectors during the course of the audit
  • Organizing the inspection rooms, teams and conducting the proper pre-audit training
  • Real life scenarios will be examined, how they were handled and what the result was

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

SPEAKER PROFILE

Danielle DeLucy

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. 
 

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.

LEARNING OBJECTIVES

  • What to expect during an FDA inspection
  • The opening meeting, daily close out and final meeting
  • Real-life scenarios and how to properly respond
  • Tips for a successful audit
  • How to handle difficult questioning, how to properly interact with the inspectors during the course of the audit
  • Organizing the inspection rooms, teams and conducting the proper pre-audit training
  • Real life scenarios will be examined, how they were handled and what the result was

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

SPEAKER PROFILE

Danielle DeLucy

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. 
 

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