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Seminar Summary:

This workshop will cover the following topics in a live classroom setting:FDA Import Operations (including the role of US Customs)FDA Export Requirements and the Certification ProgramHow FDA handles foreign inspections (see full course description)

 
 
 

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Training Course Syllabus:


FDA Import, Export and Foreign Operations for Medical Devices and Pharmaceuticals: 2-Day Workshop by Former Director of FDA CDRH

Course Description:

In today’s global environment, sustaining competitive advantage within the medical device and pharmaceutical industries requires a global product strategy that recognizes the issues involved in complying with FDA device and drug regulations and directives from other countries.

This workshop will cover the following topics in a live classroom setting:

FDA Import Operations (including the role of US Customs)
FDA Export Requirements and the Certification Program
How FDA handles foreign inspections
FDA foreign office operations
FDA interactions with foreign regulatory counterparts
The International Medical Device Regulatory Forum.

Understanding the details of how FDA regulates medical devices and pharmaceuticals outside the US and how they interact with regulators across the globe is critical in today´s diverse marketplace. FDA leverages information from various sources to make decisions regarding inspection planning, strategy development for poor quality products and ineffective recalls, and to establish appropriate measures to ensure that products entering the US marketplace are safe and effective. This seminar will provide an inside look at how FDA manages their regulatory responsibilities in these areas, while working with foreign regulators.


Areas Covered:

Imports Operations and Interactions with US Customs
Exports Operations
Types of Export Certificates (including Export permits)
Processing of Export Certificates (Inc. CDRH´s Export Certification and Tracking System (CECATS) and CDER´s Export Certificate Program)
FDA Foreign Inspection Program
The role of FDA Foreign Offices
FDA Coordination with Foreign Counterpart Regulators
The International Medical Device Regulatory Forum

Course Outline:
Day One (8:30 AM – 4:00 PM)

Registration Process: 8:30 AM

9:00 – 9.30 AM: Introductions and Overview

9:30 – 10:30: Import Operations

Import Requirements - FD&C Act Section 801
Import Procedures
Sampling Decisions/Field Examination Guidance
Sample Failures and FDA Actions; e.g. Refusal or Detention
Reasons for Refusal or Detention

10:30-10:45: Break

10:45-12.00: Import Operations continued

FDA Automated Entries – OASIS
Updated Screening Methodology – PREDICT
Manufacturer and Importer Responsibilities
Import for Export Activities
Import Statistics

12:00-1:00: Lunch

1:00-2:15: Overview of Export Program & Processes

Export Requirements – Export Reform and Enhancement Act of 1996; FD&C Act Sections 801(e) and 802

Export Certificate Processing
Handling of Requests
Electronic Submissions
Types of Certificates
Certificates for Products Legally Marketed in US

2:15-2:30: Break

2:30-3:45: Export Certificate Processing continued

Certificates for Products Not Legally Marketed in US
Tier 1 Countries

3:45-4:00: Wrap-Up/Q&A

Day Two (9:00 AM – 4:00 PM)

9:00-10:15 : The FDA Foreign Inspection Program

10:15-10:30: Break

10:30-11:45: FDA Foreign Offices and What They Do

Asia (China and India)
Latin America
Europe
Africa

11:45-1:00: Lunch

1:00-2:00: FDA and Global Regulatory Partner Coordination/Collaboration

MedicalDevices
Pharmaceuticals

2:00-3:00: History and Purpose of the International Medical Device Regulatory Forum (IMDRF)

Outgrowth of Global Harmonization Task Force (GHTF)

3:00-3:15: Break

3:15-3:45: Wrap-Up/Q&A

3:45-4:00: Closing


Seminar Summary:

This workshop will cover the following topics in a live classroom setting:FDA Import Operations (including the role of US Customs)FDA Export Requirements and the Certification ProgramHow FDA handles foreign inspections (see full course description)

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