How to Prepare For and Host a FDA Inspection and Respond to 483’s
Duration : 60 Minutes
Edwin Waldbusser, Medical Device
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, softwa Read more
In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one. You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection, the inspection process and how to respond to 483s and warning letters. How to respond and when is critically important. Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them.
Why Should You Attend:
FDA will inspect you! Are you ready? FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483’s than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.
Handout is inspection readiness checklist
Course Outline:
• Personnel preparation
• Procedure to follow during audit-what to do/ what not to do
• Facility requirements to support inspection
• Behavior during inspection-what not to sign
• Internal/ mock audits
• 483/ Warning Letter response
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
