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Webinar on Labeling - General and Special Medical Devices Requirements

  June 02, 2016  

Compliance Trainings, Online

The FDA holds you strictly liable for all labeling requirements in terms of what it says, represents or implies and even how you manage your labeling with the public. If you have a labeling problem, the FDA will say that your product is “misbranded” and, therefore, violates federal law. Sometimes the violation is easy to figure out, other times it is not. You need to go beyond the labeling regulations found in the regulations. You should be looking at what the FDA calls labeling, what it requires in certain circumstances and what you need to do in the future to prevent your labeling from violating FDA’s legal requirements. In some cases, the FDA’s treatment of labeling can be esoteric. You need to sensitize yourself to the FDA’s interpretation of labeling and how it watches what you do with labeling. Sometimes what someone else says about your product becomes your labeling and responsibility. Taking legal action for misbranding charges is relatively easy for the FDA, so it does not hesitate to go after you for those types of violations.

Areas Covered in the Session :

What constitutes labeling

Basic labeling for all devices

Prescription labeling

Consumer labeling

Customer letters treated as recalls

Unique Device Identifier

Device Sales and Promotion

Who Will Benefit:

Regulatory Affairs Departments

Quality Assurance Departments

Sales and Marketing Departments

In-house Legal Counsel for FDA law and product liability

Domestic Manufacturers

Foreign Manufacturers



Initial Importers




Organized by: Compliance Trainings
Invited Speakers:

Casper (Cap) 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 as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.

Deadline for Abstracts: 2016-06-14

For more information about this event please visit



E-mail: suzzane.d@compliancetrainings.com
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