Why you should attend:
During an inspection, FDA makes a list of things that do not appear to conform to a regulatory requirement. FDA calls them “observations” and lists them on Form FDA 483, referred to as the “483.” At a minimum, inspectional observations tell a firm where it seems to have particular problems. The problems typically are much more systemic than just the particular observations.
As you read a 483, you begin to see a picture of how the firm stacks up against FDA’s expectations. Responding efficiently and effectively to 483 observations plays a critical role in how a firm can work out its problems with FDA. A failure to respond adequately to a 483 can become a short road into a deep FDA regulatory swamp. You need to know how to avoid FDA’s regulatory swamp.
Objectives of the Presentation:
· FDA 483 inspectional observation format
· How inspectional observations are ranked in importance
· How you can respond to observations during an inspection
· How to respond to a Form FDA 483 after an inspection
· Planning and implementing a corrective action
· How to work with FDA, not around it
Who will benefit:
· Regulatory affairs professionals
· Manufacturing and Quality Assurance managers
· FDA consultants
· In-house legal counsel
· Marketing managers
· Executive and finance executives
Why you should attend:
During an inspection, FDA makes a list of things that do not appear to conform to a regulatory requirement. FDA calls them “observations” and lists them on Form FDA 483, referred to as the “483.” At a minimum, inspectional observations tell a firm where it seems to have particular problems. The problems typically are much more systemic than just the particular observations.
As you read a 483, you begin to see a picture of how the firm stacks up against FDA’s expectations. Responding efficiently and effectively to 483 observations plays a critical role in how a firm can work out its problems with FDA. A failure to respond adequately to a 483 can become a short road into a deep FDA regulatory swamp. You need to know how to avoid FDA’s regulatory swamp.
Casper Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions, participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straight forward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap now works almost exclusively on medical device issues at Olsson, Frank, and Weeda (OFW Law in Washington, D.C.)
Live Session for one participant
Price: $225.00
Corporate Live Session 4 to 10 participants in single location.
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Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $275.00