Understanding, Experience, and Technology for Compliance

Surviving an FDA Inspection: Understand the Do's and Don'ts and the Ground Rules

Many FDA regulated companies preparing for FDA inspections are not adequately prepared, which might lead to a negative outcome, as we often see with enforcement actions.

Join this webianr to know 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 of interviewing, responding, reviewing documentation, etiquette, use of certain words, body language, etc. This webinar has emphasized on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive,and being able to defend and justify... and what it takes to achieve a favorable outcome.

Areas Covered
  • What are the prohibited "Acts" and the enforcement categories that you need to deal with
  • The emphasis on systems-based inspections…and the IOM and other crucial FDA reference documents
  • Understand and apply the do's and don'ts and comprehend that preparation is the key to success
  • 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?
  • State of art tools which enables compliance to FDA guidelines at ease
  • Best of breed integrated solution for automating the process of meeting FDA requirements while lowering the associated costs that can otherwise be substantial

David David Dills
David R. Dills, Senior Consultant with PAREXEL Consulting has more than 19 years of hands-on and direct experience in quality, quality systems, regulatory affairs, compliance and validation within the life sciences and FDA regulated industry. David has been previously affiliated with well-known manufacturers and service providers and has served in various quality, regulatory and compliance management and advisory capacities. David is global industry speaker and author of technical and compliance related topics published in industry journals.

Raghuraj Gaikwad
Manager, FDA Solutions, MetricStream
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