In this webinar 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 responding to 483s and FDA warning letter.
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.
FDA is required to conduct an inspection every two years. A company that is prepared for FDA audits 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 an FDA warning letter.
Learn how to be always prepared for FDA inspections and how to handle 483s and FDA warning letter. Also understand the significance of mock audits.
Years of Experience: 30+ years
Areas of Expertise: Design Control, Risk Analysis and Software Validation of Medical Devices
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 US and internationally in the areas of design control, risk analysis and software validation for the past 9 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.View all trainings by this speaker