Webinar Search Results : 3 Upcoming webinars found.
Casper Uldriks Tuesday, July 31, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
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.

Casper Uldriks Tuesday, August 21, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 hours
Price: ¤290.00
by: Casper Uldriks
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.

Casper Uldriks Tuesday, August 28, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Casper Uldriks
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.

  • Casper Uldriks Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤189.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤189.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
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    Price: ¤189.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤189.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    Social Media Marketing & FDA Regulations
    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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    Best Practices for Handling 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    Managing Your FDA "483" Inspectional Observations
    The 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.

  • Casper Uldriks Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤390.00
    by: Casper Uldriks
    Managing Your FDA "483" Inspectional Observations
    The 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.

  • Casper Uldriks Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤190.00
    by: Casper Uldriks
    Direct-to-Consumer (DTC) Marketing: Impacts and Policy Implications
    DTC 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.

  • Casper Uldriks Recorded
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    Price: ¤390.00
    by: Casper Uldriks
    Direct-to-Consumer Advertising and FDA's Regulatory Hook
    DTC 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    Managing Your FDA "483" Inspectional Observations
    The 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤390.00
    by: Casper Uldriks
    Managing Your FDA "483" Inspectional Observations
    The 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    FDA's Tougher Import Program
    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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤390.00
    by: Casper Uldriks
    FDA's Tougher Import Program
    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. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    FDA's New Import Program for 2017
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤390.00
    by: Casper Uldriks
    FDA's New Import Program for 2017
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    Medical Device Cybersecurity : The Landscape of Quicksand
    Device 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤390.00
    by: Casper Uldriks
    Medical Device Cybersecurity : The Landscape of Quicksand
    Device 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    FDA's New Import Program for 2017
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤390.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤390.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤390.00
    by: Casper Uldriks
    FDA's New Import Program for 2017
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    Medical Device Cybersecurity : The Landscape of Quicksand
    Device 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.

  • Casper Uldriks Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤390.00
    by: Casper Uldriks
    Medical Device Cybersecurity : The Landscape of Quicksand
    Device 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.

  • Casper Uldriks Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Casper Uldriks
    FDA's New Import Program for 2017
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤390.00
    by: Casper Uldriks
    FDA's New Import Program for 2017
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤390.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    FDA's New Import Program for 2017
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤390.00
    by: Casper Uldriks
    FDA's New Import Program for 2017
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤390.00
    by: Casper Uldriks
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤190.00
    by: Casper Uldriks
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤190.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤390.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤390.00
    by: Casper Uldriks
    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. 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.

  • Casper Uldriks Recorded
    View Anytime
    Price: ¤340.00
    by: Casper Uldriks
    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.

  • Casper Uldriks Recorded
    View Anytime
    Duration:3 hours
    Price: ¤540.00
    by: Casper Uldriks
    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.

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