Other related webinars
US FDA Regulations: Food, Drugs, Biologics and M...
Friday, 9th December, 2011
Time : 02:00 PM | 11:00 AM
FDA GLP compliance in conducting non-clinical re...
Friday, 13th January, 2012
Time : 02:00 PM EST | 11:00 AM PST
FDA BIMO Inspection: Do's and Don'ts
Friday, 24th February, 2012
Time : 02:00 PM EST | 11:00 AM PST
FDA Compliant Practice for Labeling and Off-Labe...
Friday, 30th March, 2012
Time : 02:00 PM EST | 11:00 AM PST
FDA Compliant Good Laboratory Practice (GLP) For...
Friday, 11th May, 2012
Time : 02:00 PM EST | 11:00 AM PST
Conducting Successful FDA Meetings
Friday, 19th April, 2013
Time : 01:00 PM EST | 10:00 AM PST
Best Practices for Preparation for, Behavior dur...
Friday, 5th December, 2014
Time : 01:00 PM EST | 10:00 AM PST
Understanding the Mindset of an FDA Employee
Thursday, 2nd April, 2015
Time : 11:30 AM EDT | 04:30 PM CET
FDA's Import Requirements and Managing the Impor...
Friday, 24th April, 2015
Time : 11:30 AM EDT | 04:30 PM CET
UDI and GUDID - The Unique Device Identification...
Friday, 8th May, 2015
Time : 01:00 PM EST | 10:00 AM PST
Good Distribution Practices
Friday, 26th June, 2015
Time : 02:00 PM EST | 11:00 AM PST
Premarket and Postmarket Data Collection - A Fas...
Friday, 28th August, 2015
Time : 01:00 PM EDT | 10:00 AM PDT
FDA’s ‘Refuse to Accept’ Process for 510(k...
Friday, 30th October, 2015
Time : 02:00 PM EDT | 11:00 AM PDT
FDA Medical Device Regulation – Effective Cor...
Wednesday, 9th December, 2015
Time : 02:00 PM EDT | 11:00 AM PDT
Protecting Patient Privacy
Monday, 25th April, 2016
Time : 01:00 PM EDT | 10:00 AM PDT
Best Practices for FDA Inspection: Preparation, ...
Friday, 27th May, 2016
Time : 01:00 PM EST | 10:00 AM PST
Navigating FDA Import Requirements for Food, Dev...
Friday, 3rd March, 2017
Time : 01:00 PM EST | 10:00 AM PST
FDA Warning Letter, FDA-483's and Import Alerts ...
Friday, 13th October, 2017
Time : 01:00 PM EST | 10:30 AM PST
A Bulletproof, Cost-efficient Supplier Managemen...
Friday, 12th January, 2018
Time : 01:00 PM EDT | 10:00 AM PDT
FDA Good Clinical Practice (GCP) for Drugs, Biol...
Friday, 8th June, 2018
Time : 01:00 PM EST | 10:00 AM PST
FDA Case Scenarios – Best Practices for Managi...
Friday, 14th December, 2018
Time : 01:00 PM EDT | 10:00 AM PDT
Registries - The latest FDA trends, Reducing Cos...
Friday, 26th June, 2020
Time : 01:00 PM EST | 10:00 AM PST
CAPA and Critical Documentation of Clinical Tria...
Friday, 7th May, 2021
Time : 01:00 PM EST | 10:00 AM PST
Fellowship in Clinical Cardiology
Thursday, 4th November, 2021
Time : 01:00 PM EST | 10:00 AM PST
Fellowship in 2D Echocardiography – Edition II...
Friday, 7th January, 2022
Time : 01:00 PM EST | 10:00 AM PST
FDA and Medical Device Advertising in the 21st C...
Friday, 20th January, 2023
Time : 01:00 PM EST | 10:00 AM PST
Capturing Justifications in Change Control, Risk...
Friday, 27th January, 2023
Time : 01:00 PM EST | 10:00 AM PST
FDA Good Clinical Practice and More! HOW TO PLAN...
Friday, 10th February, 2023
Time : 01:00 PM EST | 10:00 AM PST
How FDA Trains Its Investigators to Review CAPA,...
Friday, 31st March, 2023
Time : 01:00 PM EST | 10:00 AM PST
How FDA Evaluates Your Quality Management System...
Thursday, 22nd February, 2024
Time : 01:00 PM EST | 10:00 AM PST
Recorded Webinar
Navigating FDA Import Requirements for Food, Devices, Drugs and other FDA Regulated Products
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Navigating FDA’s requirements in order to successfully import FDA regulated products is important for any company that relies on sales revenue from foreign made products regulated by FDA. In order to assure that the imported product does not get detained or refused entry the importer should be fully informed of FDA requirements for foods, medicines, medical devices, cosmetics, and radiation emitting devices. In addition there are requirements for general importation enforced by the Customs and Border Protection (CPB) section of the Department of Homeland Security.
During this course we will provide information on FDA’s authority and the requirements for FDA regulated products.
What can happen if you are not familiar with FDA and/or CPB requirements? You may find that you have purchased a large amount of a foreign made FDA product, which do not meet FDA’s requirements. FDA may refuse entry, or you may incur a long delay in the importation, both of which can be very costly for the importer.
Key goals of the Webinar will include:
- Become familiar with the product categories regulated by FDA.
- Know how to select foreign suppliers that can provide products that meet FDA requirements
- Know the requirements for specific types of FDA regulated products
- Become familiar with the procedures FDA follows to process an import entry
- Know how to file FDA and CPB entries that will meet the requirements
- Know who to negotiate with FDA when an import problem occurs
- Know how to train your own employees in FDA/CPB requirements
- Attain the ability to have a high level (100%) of success on each import entry.
Who should attend
This topic applies to personnel / companies conducting FDA Regulations & FDA Meetings: The employees who will benefit most include:
However, if you are already familiar with the Sponsor-Investigator process in clinical trials, you may recommend this webinar to anyone in your company or research facility that might benefit from this course.
Content Disclaimer
Contents in our website are from external websites. Links to and content from external website are provided for the convenience of users. Biopractice.com takes no responsibility for the content of such links and websites.