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Individual e-Learning



Preparing for and Passing an FDA Inspection: A-Z

Strategies, tactics, hints and tips to guarantee a cost-effective first-time pass through an FDA inspection

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Benefits of attending for you and your company

At the end of the course you will...

understand the mechanics and extent of an FDA inspection

be fully aware of FDA’s risk management and quality systems approaches to GMP compliance

realize how FDA’s 21st century GMP initiatives have changed the inspection landscape

know how to prepare yourself and your company for an inspection

recognize the traps and pitfalls facing you in an inspection

know why you pass or fail an inspection in the first fifteen minutes

understand why you absolutely cannot afford to fail an FDA inspection

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Who Should Attend

Senior management who will deal with FDA inspectors, regulatory affairs professionals and quality assurance personnel.

Production, engineering, validation, quality control and research and development staff who will be facing an FDA inspector will find this seminar essential preparation and key to the company’s success at the inspection.

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Course Language

The course is presented in English

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Course Overview

The world of GMP compliance has dramatically changed with FDA stressing pre-approval inspections, risk management, investigations and CAPA, quality systems approaches, and process and analytical technology (PAT) applications.

If you last passed an FDA inspection more than four years ago, or if you have never faced an FDA inspection, you will be unprepared for FDA’s 21st-century inspection methods. This course provides all the background information and key techniques needed to guarantee a cost-effective, first-time pass through an FDA inspection – whether for a pharmaceutical product, an active pharmaceutical ingredient (API), a medical device or a biological product.

All API, medical device, diagnostic product manufacturer, biotechnology product or pharmaceutical manufacturers – no matter in which country they operate – must pass an on-site FDA inspection of their facilities and operations if products are to be sold in the United States.

This seminar is designed to provide background and insight into the inspection process, as well as practical strategies and tactics that a company must know and implement in order to have the potential to pass an inspection the first time through.

The seminar covers everything you need to know — from the background to the inspection, including the importance of the commitments made in the product application (the DMF, the NDA, the BLA or the PMA). In addition we will discuss the differences between good science and GMP compliance issues. The inspection process itself will be analyzed and reviewed in a manner that will allow you to immediately begin effective strategizing on how to pass the inspection. Nothing has been left out. The course touches on everything, and we do mean everything, you need to know to have a smooth and successful inspection.

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Course Outline

  • FDA organization: who does what within FDA
  • FDA inspection objectives
  • FDA’s 21st-century initiatives and their impact on inspections:
    - Quality systems approaches and inspections
    - Risk management
    - Changes to FDA’s ONDC review process
    - Process and analytical technology (PAT)
    - Electronic records/electronic signatures (21CFR11)
  • The approval process and how inspections are planned and triggered
  • The differences between a GMP and a pre-approval inspection (PAI)
  • Strategies of companies that have been successful; Lessons from companies that have failed
  • Paying for an inspection
  • Preparing for an inspection: key elements that must be covered
  • Training your company staff
  • How to handle an inspector
  • Key do’s and don'ts: things that will kill you during an inspection
  • What the inspector is looking for in:
    - Batch documentation
    - Stability studies
    - Validation documentation
  • FDA's inspection techniques: system inspections explained
  • FDA strategies for preparing for rapid inspections
  • FDA’s expectations from:
    - Your CAPA systems
     (Corrective Actions and Preventive Actions)
    - Your environmental trending reports
  • What documents you need to show the FDA
  • Effective investigation of:
    - Complaints
    - Out-of-specifications, out-of-trends
  • Environmental monitoring requirements
  • What to say (and what not to say) to an inspector
  • The five validation inspections: what FDA looks for in validations
  • Bribery, corruption, fraud: how to entertain FDA legitimately
  • Documentation requirements: before, during and after the inspection
  • Follow-up by FDA after an inspection
  • FDA application integrity policy and import alert system
  • Follow-up by the company after an inspection
    - What to say, and how to say it
    - Rescuing yourself from a marginal inspection

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Previous Participant Testimonials

The course on "Passing an FDA Inspection" was extremely useful, both in your presentation content and in your response to the attendees' questions.
Michael Bartlett, GlaxoSmithKline

I just wanted to say what a wonderful course — I was hooked from start to finish. It's been a real eye-opener for me. Thank You.
Christine McMullins, Eli Lilly

Thank you for the very informative and enjoyable course you presented yesterday. I really enjoyed it, and will certainly be recommending the course to others.
Rosie O’Shea, Celltech-Chiroscience



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