How to Prepare For and Host a FDA Inspection and Respond to 483's

A company that is ready for an FDA inspection is less likely to receive 483 observations than a disorganized one. This 60-minute webinar covers how to prepare for and host an FDA inspection, and what to do if a Form 483 or warning letter follows.

You'll look at the types of FDA inspections, assigning people to specific inspection tasks, setting up front room and back room facilities, the value of mock audits, and how staff should behave, including what not to sign.

The session also explains the FDA's rights during an inspection, the documents you are not required to show, and why the timing and content of your 483 response matter so much.

• Prepare personnel and assign roles for an FDA inspection
• Set up facilities, including front and back rooms, to support the inspection
• Use internal and mock audits to get ready
• Follow the right procedures and conduct during the inspection
• Explain FDA's rights and which documents you need not provide
• Respond to 483 observations and warning letters effectively and on time

• Types of FDA inspections
• Preparing personnel and assigning inspection tasks
• Facility requirements: front room and back room
• Internal and mock audits
• Procedures during the audit: what to do and what not to do
• Behavior during the inspection, including what not to sign
• FDA rights and documents you don't have to show
• Responding to 483s and warning letters

The FDA will inspect you, so the question is whether you're ready. Preparation lowers the chance of 483s, and knowing how to respond to a 483 reduces the chance it turns into a warning letter.

The webinar suits medical device companies marketing in the U.S. and their executives, regulatory, QA, quality and compliance managers, auditors, quality engineers, CAPA specialists, management representatives, consultants and anyone who may deal directly with FDA officials.

This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, fields. The employees who will benefit include:

• Executive/senior management
• Regulatory management
• QA management
• Any person who may have direct interaction with FDA officials
• Consultants
• Quality system auditors
• Quality Engineers
• Compliance Specialists
• Compliance Leaders
• CAPA Specialists
• Management Representatives
• Compliance Managers and Directors
• Quality Managers and Directors
• Consultants and Contractors

Edwin Waldbusser, is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.