Speaker Profile


Casper Uldriks

ex-FDA Expert and former Associate Center Director of CDRH, Olsson

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. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture. Professional credentials: JD – Suffolk University, licensed in Massachusetts and the District of Columbia; M.Div in psychology – Boston University with internship through Harvard University.

  •  Tuesday, July 31, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • ¤150.00
FDA's New Import Program for 2018

The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry.

  •  Tuesday, August 21, 2018
  • 09:00 AM PDT | 12:00 PM EDT,
  • 3 hours
  • ¤290.00
3-Hour Virtual Seminar: FDA Imports Require Precision in 2018

Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct, or else, FDA's entry requirements with detain your product. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.

  •  Tuesday, August 28, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • ¤150.00
FDA's Revolutionary Change in Software Regulation

Congress recognized that FDA struggles with software regulation. So, Congress removed some software out of FDA's jurisdiction. Now FDA must revise its premarket and postmarket software regulatory approach, including mobile apps. Using voluntary standards in premarket submissions can be used more effectively. Even more dramatic, FDA's new Digital Health initiative turns FDA's premarket clearance program on its head.

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  • Recorded
  • View Anytime
  • ¤189.00
Managing FDA 483s: Before, During and After the Inspections

The FDA Form 483 represents an inspectional record of objectionable conditions observed by the FDA investigator during an inspection of a manufacturing establishment. The inspection will cover a certain set of regulations that apply to the particular manufacturer's operations. Products regulated by FDA have different manufacturing, records and reporting regulations.

  • Recorded
  • View Anytime
  • ¤189.00
Rational Predictions for FDA inspections

The webinar covers factors considered by FDA before, during and after an inspection that can be used to predict your inspectional vulnerability. Once you know some key points, you will see that FDA's approach to inspections follows well-established procedures and risk criteria that enables FDA to characterize your firm's compliance. Usually the only way FDA will let you know about your profile is when an official action is indicated. That is not a good thing. Otherwise, you hear very little and even then, you may wait a long time. The cloud of doubt can plague a firm for months.

  • Recorded
  • View Anytime
  • ¤189.00
Your Social Media Marketing is Under FDA's Microscope

Social media has become a primary vehicle for reaching buyers, both professional healthcare providers and consumers. The consumers can post whatever they wish, whether it is true, false, an opinion or simply as a joke.

  • Recorded
  • View Anytime
  • ¤189.00
Manage Your FDA Inspection Before It Happens

The FDA conducts various types of inspections depending on what the firm is doing. Inspections follow fairly predictable patterns. You can identify what factors are relevant for your inspections and how the FDA will work with them. The goal of the seminar is to help you figure out what is relevant for how FDA looks at you. Establishing a well-reasoned inspectional strategy on the basis of relevant FDA factors, and how an inspection unfolds, you avoid or mitigate unnecessary policies and procedures that are premised on a defensive stance or an ad hoc management style, which is usually so anxiety laden that the firm becomes its own worst enemy.

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