This course provides 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.

Areas Covered:-

• Types of Inspections
• Preparation
  • Dedicated personnel for inspection
  • Facility resources to support the inspection
  • Internal audits
• SOP for inspections
• Behavior 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:-

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.

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 the FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.

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;
  • Product Development;
  • Engineering;
  • Manufacturing;
• Complaint Handling
• Personnel new to the regulated industry
• Training personnel
• Document Control Personnel