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Speaker Profile
CASPER ULDRIKS

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s food and medical device programs as a field investigator, served as a senior manager in the Office of Compliance, and as an Associate Center Director for regulatory guidance and government operations. He developed enforcement actions and participated in the implementation of new statutory requirements, such as FDA’s import/export program. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward, and practical value. He understands how the FDA thinks, operates, and where it is headed. Cap is the President of Encore Insight, LLC, a consulting service for FDA matters.


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Showing 1 to 12 of 12 (1 Pages)
$150.00
BEST SELLER - Fatal FDA Inspection Mistakes

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
BEST SELLER - Fatal FDA Inspection Mistakes

When FDA shows up at your door to announce an inspection, what do you think is going to happen? More importantly, what are you going to do?An ex-FDA investigator will conduct this webinar to share an “insider’s” perspective about inspections. What’s important, what’s not, and what is a fatal mistake on the part of a firm. Firms need an established FDA inspection protocol that describes what happens during a..

$150.00
BEST SELLER - FDA’s Scrutiny of Social Media Off-Label Promotion

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
BEST SELLER - FDA’s Scrutiny of Social Media Off-Label Promotion

FDA’s regulation of social media operates as a moving target. What is OK or not OK remains vague, perhaps purposely so. All social media platforms provide an easy common way to cross the FDA’s legal boundaries for “misbranding” your product, whether knowingly or unknowingly. In the end, your firm’s executive management ends up with the legal responsibility for the enforcement action. A regulatory monster lu..

$150.00
BEST SELLER - How to Use Foreign Trade Zones and Bonded Warehouses in the U.S.

 Casper Uldriks
 Recorded Webinar
 60 minutes
 Download Catalog
BEST SELLER - How to Use Foreign Trade Zones and Bonded Warehouses in the U.S.

The use of Foreign Trade Zones and Bonded warehouses for FDA regulated products create different opportunities and different obligations. Firms need to understand the requirements of each to use them to their advantage. The imported products will have different regulatory requirements depending on the option chosen. In some cases, the FDA does not give you an option and the outcome is expensive. Firms also ..

$200.00
Critical Planning for Exporting Devices to the EU

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
Critical Planning for Exporting Devices to the EU

Exporting devices to the EU has new EU legal requirements. A device must have a valid CE mark. You must renew your CE mark certification every three years.  If you do not, your products cannot be marketed legally in the EU. If your product is not marketed in the U.S. Many U.S. devices are legally marketed in the EU, not the U.S., renewing your CE certification takes planning, a lot of planning. It is n..

$200.00
EU Medical Devices Regulation: CE Mark Expiration and the EU Refusal of Your Exports

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
EU Medical Devices Regulation: CE Mark Expiration and the EU Refusal of Your Exports

FDA and the EU have tried to harmonize device regulatory requirements for over 25 years. Major differences between the FDA and the EUincludepremarket authorization (CE Mark), complaint investigations, postmarket surveillance, and reports. The EU’s new Medical Devices Regulation (MDR) incorporates more rigorous regulatory requirements for those areas and in some cases outpaces the FDA’s requirements. The FDA..

$200.00
FDA and Management Responsibility for Social Media Use

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
FDA and Management Responsibility for Social Media Use

The use or participation in social media can lead to some surprising outcomes with the FDA. The sweeping statutory definition of “labeling” covers the use of information that appears in social media. There are several platforms that can present information either by you or a third-party, all of which can become an action by the FDA against the management’s actions or inactions. Firms should develop and impl..

$200.00
FDA Import Program with COVID-19

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
FDA Import Program with COVID-19

Importing FDA regulated product faces new challenges, new risk management procedures, and mitigation of business consequences that will affect corporate profits. Basic issues should be evaluated and updated to help you plan for unprecedented problems and your helplessness to escape the trauma. The COVID-19 creates a global bondage on commerce and drains, if not dries up, the supply of necessary products to ..

$200.00
FDA Inspections: Prepare and Survive

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
FDA Inspections: Prepare and Survive

FDA conducts establishment inspections to determine a firm’s conformance to applicable regulatory requirements. Inspections vary based on the type of product you make or plan to make. FDA prioritizes domestic and foreign inspection assignments based on three factors. However, with the current public health crisis with COVID-19, FDA is overwhelmed with work at this time, so it will likely rely on new approac..

$200.00
FDA’s and U.S. Custom’s Import Entry Program

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
FDA’s and U.S. Custom’s Import Entry Program

The webinar address the critical elements of information required to present a product for entry into the U.S.  We will cover what information for FDA is mandatory. You must use the new software program, Automated Commercial Environment (ACE), you need to decide on who will do that, establish operational procedures and what to do if your entry is detained. The course will explain how you can make your ..

$200.00
FDA’s Scrutiny of Social Media and Corporate Responsibility

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
FDA’s Scrutiny of Social Media and Corporate Responsibility

Off-label promotion falls within the scope of labeling requirements as defined by the Federal Food, Drug, and Cosmetic Act, as amended (FDCA).  FDA’s application of labeling requirements to the information posted in social media of any type creates a new field of enforcement opportunity, one that may catch you by surprise. If off-label statements, whether express or implied, end up directly or indirect..

$200.00
Managing an FDA Foreign Inspection

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
Managing an FDA Foreign Inspection

Agreeing to an FDA foreign inspection requires careful preparation on a firm’s part. If you do not manage your inspection wisely, you will set yourself up for disaster. We will cover fundamental issues, such as pre-inspection tasks, preparing your documents and having an interpreter before, during and after the inspection. We will also address how you should respond to inspectional problems noted by the FDA..

$200.00
The Risks Embedded in Using Social Media for Product Promotion

 Casper Uldriks
 Recorded Webinar
 60 Minutes
 Download Catalog
The Risks Embedded in Using Social Media for Product Promotion

What a firm can say in social media and what an individual can say, are two different worlds, but it is easy to jump unknowingly from the individual to the corporate world of what is legally acceptable to FDA. Firms need to extrapolate corporate boundaries for how they can use and not use social media. What a firm says and how firms deliver a message are equally laden with risk. And ripe for FDA’S administr..

Showing 1 to 12 of 12 (1 Pages)