How to Prepare for and Host a FDA Inspection and Avoid 483’s (based on practical experience)
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 about the types of FDA inspections, necessary preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection, the value of mock audits, how company personnel should conduct themselves during the inspection, how the inspection will unfold and how to respond to 483’s.
Course Objective:
• Types of inspections
• Preparation
o Dedicated personnel for inspection
o Facility resources to support the inspection
o Internal audits
o Mock audits
• SOP for inspections
• Behaviour during inspection-what to say, what not to say
• Inspection process
• 483 response process
Course Outline:
Topics covered include:
• Types of FDA inspections
• Inspection SOP preparation
• Preparation –people, facilities
• Mock audits
• How the inspection proceeds
• Responding to 483’s
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 personnel in:
Medical device development/ manufacturing
• Regulatory management
• Engineering
• Corporate Management
• Quality Assurance
• Quality Control
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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