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483 Covers a Broad Gradation of Problems
Date
Oct 26, 2021 - 10:00 AM
Link to Website
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
Netzealous LLC DBA - Compliance4All,
Fremont,
CA,
US,
ZIP: 94539
Phone: 18004479407
Ticket Price: $ 150.00
Overview:
How you respond to the 483 should provide the foundation for any future
communication with the FDA about a particular inspection. Understanding how
FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your
favor as it is well organized, succinct and provides proper documentation.
Why You Should Attend:
Your failure to understand and properly respond to a 483 issued to you at the
conclusion of an FDA inspection may quickly lead to an administrative or a
legal action that can have an immediate adverse effect on a firm’s business.
Areas Covered in the Session:
What the 483 means
How to interpret the 483 - "How bad is it?"
Managing the 483 discussion with the FDA at the conclusion of the inspection
Responding to the FDA in writing
Who Will Benefit:
Manufacturers
FDA Consultants
Legal Counsel
Regulatory Affairs Managers
Quality Assurance Staff
Speaker Profile:
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” 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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
How you respond to the 483 should provide the foundation for any future
communication with the FDA about a particular inspection. Understanding how
FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your
favor as it is well organized, succinct and provides proper documentation.
Why You Should Attend:
Your failure to understand and properly respond to a 483 issued to you at the
conclusion of an FDA inspection may quickly lead to an administrative or a
legal action that can have an immediate adverse effect on a firm’s business.
Areas Covered in the Session:
What the 483 means
How to interpret the 483 - "How bad is it?"
Managing the 483 discussion with the FDA at the conclusion of the inspection
Responding to the FDA in writing
Who Will Benefit:
Manufacturers
FDA Consultants
Legal Counsel
Regulatory Affairs Managers
Quality Assurance Staff
Speaker Profile:
Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” 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.
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
Event Categories
Keywords: Educational, Health , HealthCare , business , FDA, medical
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