The "FDA Inspections: What Regulators Expect and How to Prepare" conference has been added to Research and Markets' offering.

This is a practical, hands-on course designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection efficiently, effectively and successfully. Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters.

The course will go through what typically goes on during an FDA Inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will emphasize and focus on the critical and vital elements that you should do or not do during the inspection. Typically, FDA inspections can be highly structured and there are procedures that are to be followed as you prepare for state of readiness. It is important for anyone who might be involved in the inspection to be aware of these procedures, including all employees and personnel to ensure there are no surprises.

The course will also provide information for inspections conducted by international agencies as well as non- FDA agencies, including self-inspections for manufacturing and the famous FDA Mock Inspection or Mock Audit. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled inspection, what to expect during an inspection and what follow up to expect after an inspection.

Areas Covered:

  • FDA's Inspectional Authority and History
  • FDA Inspection Program Overview
  • Key factors for a successful FDA inspection
  • Quality System Readiness
  • Organization Readiness
  • Manage Inspection Outcomes
  • Information and Documentation
  • How a firm should prepare for an FDA inspection?
  • Ways to train employees in view of the inspection
  • How to ensure that required documentation is in place
  • How to interact with the investigator-DO's and DON'T's
  • What companies should do when the inspection ends
  • How to reply to 483's and warning letters

Agenda:

Day 1

  • FDA's Inspectional Authority and History
  • FDA Inspection Program Overview
  • Key factors for a successful FDA inspection
  • Quality System Readiness
  • Organization Readiness
  • Manage Inspection Outcomes
  • Information and Documentation
  • How a firm should prepare for an FDA inspection?
  • Ways to train employees in view of the inspection
  • How to ensure that required documentation is in place
  • How to interact with the investigator-DO's and DON'T's
  • What companies should do when the inspection ends
  • How to reply to 483's and warning letters

Day 2

  • Legal implications of non-compliance
  • Why inspections are conducted and by what statutory authority
  • The emphasis on systems-based inspections... and the IOM and other crucial FDA reference documents
  • What is subject to FDA purview and what's off-limits
  • Understand and apply the do's and don'ts and comprehend that preparation is the key to success
  • What are the prohibited "Acts" and the enforcement categories that you need to deal with?
  • What you need to know and do to prepare for, during and even after the inspection... and why your inspection response team is key
  • The company's Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel
  • How to respond to findings and facilitating the documentation and remediation process... and reaching final closure
  • Define clear responsibilities, roles and goals for personnel involved in FDA inspections and SOP development
  • Exit Interview
  • FDA interviewing employees and personnel
  • Mock Inspections and Mock Audits and why role playing is important

For more information about this conference visit https://www.researchandmarkets.com/research/zn67cv/fda_inspections?w=4