Preparing for and Passing an FDA Inspection

מידע כללי
משך הפעילות: יום לימודים מלא
שעות:  09:00-17:00
עלות: 2,150 ש"ח + מע"מ
נקודות זכות: 1
מק''ט: 13437
שפת הקורס: אנגלית
על הקורס

The United States Food and Drug Administration takes its role of a consumer protection agency very seriously and has developed the toughest inspection program of any regulatory agency in the world. Any bulk pharmaceutical chemical manufacturer, medical device, diagnostic product manufacturer, biotechnology product or pharmaceutical manufacturer must pass an on-site FDA inspection of its operations if products are to be sold in the United States.

This seminar is designed to provide background and insight into the inspection process, and to provide 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 will cover issues regarding all aspects of the inspection from how to apply for an inspection to how to meet the inspector on first morning, to preparing validation master plans, to responding to an inspection. The course will touch on everything, and we do mean everything, you need to know to have a smooth and successful inspection

קהל היעד

Senior management who will deal with an FDA inspector, regulatory affairs professionals and quality assurance personnel.
Production, engineering and research and development staff who will also meet the inspector will find this seminar of great value

Preparing for and Passing an FDA Inspection
התועלת שתופק

At the end of the course you will

  • understand the mechanics and extent of an FDA inspection
  • 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
השאר פרטים למידע נוסף
  • שם מלא
  • דוא''ל
  • טלפון
  • הערות
  • שלח
תכני הקורס
  • FDA organization: who does what
  • FDA inspection objectives
  • 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 you must cover
  • Training your company staff
  • How to handle an inspector
  • Key Do’s and Do Not’s
    • things that will kill you during an inspection
  • What the inspector is looking for FDA's inspection techniques
    • system inspections explained
  • FDA strategies for preparing for rapid inspections
  • What to say and what not to say to an inspector
  • Keeping your sanity
  • 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
אודות המרצה

Mr. Michael Anisfeld

is senior consultant for Globepharm Consulting specializing in GMP/Quality activities for the healthcare manufacturing industries. In his current position he numbers among his clients United Nations Agencies, national regulatory agencies (including the US-FDA) and more than 200 pharmaceutical, medical device, biotechnology and bulk pharmaceutical companies in North America, Europe and Asia.

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