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FDA Import, Export and Foreign Operations for Medical Devices and Pharmaceuticals

By:
Larry Spears, Former Division Director and Deputy Office Director for the Office of Compliance - FDA CDRH
Coming soon.. Please contact customer care for new schedule

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.

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar



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


Who Will Benefit:

  • Regulatory Affairs
  • Quality Assurance
  • Compliance
  • Data Management
  • Data Monitoring
  • Biostatistics
  • Business Planning Executives
  • In-house Legal Counsel and Contract Specialists
  • Venture Capitalists
  • Business Acquisition Executives
  • Owners of New or Developing Import/Export Firms
  • International Trade Managers
  • Import Brokers
  • Investors
  • Logistics Managers
  • Sales Managers
  • Senior Associates, Managers, Senior Directors




Course Outline:

Day One (8:30 AM – 4:00 PM) Day Two (9:00 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


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






Meet Your Instructor

Larry Spears
Former Division Director and Deputy Office Director for the Office of Compliance - FDA CDRH

Larry Spears is an independent consultant to the medical device industry and President of L.Spears Consulting, LLC. He has over 30 years experience with the US Food and Drug Administration first as an field investigator and later as a compliance officer, Division Director and Deputy Office Director for the Office of Compliance, at FDA's Center for Devices and Radiological Health. In his last FDA position, he regularly made policy decisions regarding regulatory and enforcement matters including the appropriate actions to manage companies with chronic regulatory problems and ineffective recalls. He supervised the Import Operations Group in the Office of Compliance and has delivered several talks on import and export operations. Larry also served as a Director in the Deloitte & Touche Enterprise Risk Services Program, where he provided consulting services for the medical device and pharmaceutical industries. In his current role, he conducts regulatory audits and FDA mock inspections and provides regulatory assistance in responding to FDA 483s and enforcement actions, and in supporting companies in building and maintaining Quality Management Systems.





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