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.
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.
Speaker: Casper Uldriks | View Anytime | Price: ¤189.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤189.00 | View DetailsSocial 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤189.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤189.00 | View DetailsSocial 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsThe FDA list of inspectional observations (aka 483) tells the FDA the kinds of deviations a firm has and how serious they are. The 483 and the inspection report provide the factual foundation for the FDA to determine whether official action is appropriate.
Speaker: Casper Uldriks | View Anytime | Duration: 90 Minutes | Price: ¤190.00 | View DetailsDTC involves various platforms to convey a message, social media, broadcast media, print media and the internet. Each of these platforms have special criteria to define what you can and cannot do. FDA treats those criteria in a stringent manner. FDA "trolls" these platforms to catch firms running fowl of the FDA's guidance on DTC. If they catch you, they can.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsThe FDA list of inspectional observations (aka 483) tells the FDA the kinds of deviations a firm has and how serious they are. The 483 and the inspection report provide the factual foundation for the FDA to determine whether official action is appropriate.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsDevice cybersecurity programs protect and the performance of device based software or standalone software to assure the safe use of the device. The development and implementation of cybersecurity programs in the device industry requires the use of the FDA's premarket and postmarket information requirements to get to market and to stay on the market. The FDA relies on the use of voluntary standards developed by the National Institute of Standards and Technology (NIST) and voluntary information sharing organizations to meet cybersecurity challenges. Manufacturers have additional business issues to address, such as recovery and public disclosure of cyberattacks, especially when private medical records are extracted, which leads to fines in the millions of dollars per intrusion.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsDevice cybersecurity programs protect and the performance of device based software or standalone software to assure the safe use of the device. The development and implementation of cybersecurity programs in the device industry requires the use of the FDA's premarket and postmarket information requirements to get to market and to stay on the market. The FDA relies on the use of voluntary standards developed by the National Institute of Standards and Technology (NIST) and voluntary information sharing organizations to meet cybersecurity challenges. Manufacturers have additional business issues to address, such as recovery and public disclosure of cyberattacks, especially when private medical records are extracted, which leads to fines in the millions of dollars per intrusion.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsCongress 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsImporting 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.
Speaker: Casper Uldriks | View Anytime | Duration: 3 hours | Price: ¤340.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Price: ¤190.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsThe 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).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsIn this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsIn this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsFDA’s import and export programs are complex, detailed and undergo changes without notice to the public.
Speaker: Casper Uldriks | View Anytime | Duration: 2 Days | Price: ¤1,045.00 | View DetailsIf you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsIn this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsIn this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsIf you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsIn this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsIf you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 4 Hours | Price: ¤495.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsFDA steadily expands the scope and restrictions for the promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume you're talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤340.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, on a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤190.00 | View DetailsIf you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: ¤595.00 | View DetailsThe FDA list of inspectional observations (aka 483) tells the FDA the kinds of deviations a firm has and how serious they are. The 483 and the inspection report provide the factual foundation for the FDA to determine whether official action is appropriate.
Speaker: Casper Uldriks | View Anytime | Duration: 90 Minutes | Price: ¤390.00 | View DetailsDTC involves various platforms to convey a message, social media, broadcast media, print media and the internet. Each of these platforms have special criteria to define what you can and cannot do. FDA treats those criteria in a stringent manner. FDA "trolls" these platforms to catch firms running fowl of the FDA's guidance on DTC. If they catch you, they can.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsThe FDA list of inspectional observations (aka 483) tells the FDA the kinds of deviations a firm has and how serious they are. The 483 and the inspection report provide the factual foundation for the FDA to determine whether official action is appropriate.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsDevice cybersecurity programs protect and the performance of device based software or standalone software to assure the safe use of the device. The development and implementation of cybersecurity programs in the device industry requires the use of the FDA's premarket and postmarket information requirements to get to market and to stay on the market. The FDA relies on the use of voluntary standards developed by the National Institute of Standards and Technology (NIST) and voluntary information sharing organizations to meet cybersecurity challenges. Manufacturers have additional business issues to address, such as recovery and public disclosure of cyberattacks, especially when private medical records are extracted, which leads to fines in the millions of dollars per intrusion.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsDevice cybersecurity programs protect and the performance of device based software or standalone software to assure the safe use of the device. The development and implementation of cybersecurity programs in the device industry requires the use of the FDA's premarket and postmarket information requirements to get to market and to stay on the market. The FDA relies on the use of voluntary standards developed by the National Institute of Standards and Technology (NIST) and voluntary information sharing organizations to meet cybersecurity challenges. Manufacturers have additional business issues to address, such as recovery and public disclosure of cyberattacks, especially when private medical records are extracted, which leads to fines in the millions of dollars per intrusion.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsThe 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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsCongress 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsImporting 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.
Speaker: Casper Uldriks | View Anytime | Duration: 3 hours | Price: ¤540.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsThe 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.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Price: ¤390.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsThe 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).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsIn this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsIn this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsFDA’s import and export programs are complex, detailed and undergo changes without notice to the public.
Speaker: Casper Uldriks | View Anytime | Duration: 2 Days | Price: ¤1,395.00 | View DetailsIf you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsIn this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsIn this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsIf you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsIn this interactive session author will discuss the impact of the COVID-19 and the FDA's required information for the PREDICT software screening prior to entry and Custom's Harmonized Tariff Schedule (HTS).
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsIf you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 4 Hours | Price: ¤845.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, in a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsFDA steadily expands the scope and restrictions for promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume your talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsFDA steadily expands the scope and restrictions for the promotion of products under its jurisdiction. Whatever and where ever to want to talk about your product, just assume you're talking to FDA.
Speaker: Casper Uldriks | View Anytime | Duration: 3 Hours | Price: ¤540.00 | View DetailsFDA's sweeping definition of labeling includes what is said or represented, even by images, on a social media platform.
Speaker: Casper Uldriks | View Anytime | Duration: 60 Minutes | Price: ¤390.00 | View DetailsIf you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
Speaker: Casper Uldriks | View Anytime | Duration: 6 Hours | Price: ¤945.00 | View Details