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When FDA shows up at your firm to conduct an inspection you need to create a good first impression and show that you know what you are doing in terms of conducting an inspection. If you do not know or understand the basic elements of an inspection, the process can become overwhelming and lead to situations that work against the firm. The conclusion of the inspection gives you the opportunity to gauge FDA's response to the inspection and, if appropriate, prepare a response to FDA. FDA inspections are a good example of where prior planning can avoid costly and long term negative effects. 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.
Key Learning Objectives
- Types of Inspections
- Preparation
- Dedicated personnel for inspection
- Facility resources to support the inspection
- Internal audits
- Mock audits
- SOP for inspections
- Behavior during inspection-what to say, what not to say
- Inspection process
- 483 response process
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Edwin Waldbusser
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. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
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