Introduction

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA inspection. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

Area Covered In The Webinar

  • Types of Inspections
  • Preparation
  • Dedicated personnel for inspection
  • Facility resources to support the inspection
  • Internal audits
  • SOP for inspections
  • Behaviour during inspection: What to say and do, and what NOT to say and do
  • Inspection process
  • How and when to craft a written response

Why should you attend?

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?

The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

Without adequate preparation and cross-functional communication, it is difficult to manage a good FDA inspection. Your goal is to illustrate your firm is in substantial compliance with all regulations, but also to respond to the inspector’s questions or concerns in a timely manner. This webinar will identify systems and processes, and recommended tactics, to make the inspection as painless as possible.

Who Will Benefit

This webinar will provide valuable assistance to all regulated companies, since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

Quality Auditors

Compliance Officers

Executive Management

Managers/Directors/Supervisors and Personnel related to:

  • Regulatory Compliance and Regulatory Affairs
  • Quality Management System
  • Quality Assurance
  • Quality Control
  • Product Development
  • Engineering;
  • Manufacturing
  • Risk Management

Complaint Handling

Personnel new to the regulated industry

Training personnel

Document Control Personnel    

ENROLLMENT OPTIONS

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Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality sys Know More

Jeff Kasoff