dynamic, current, and comprehensive functional trade

U.S. Trade Compliance for Medical/Biotech/PharmaDynamic, current, and comprehensive functional trade compliance training developed

specifically for medical, biotech, and pharmaceutical organizationsspecifically for medical, biotech, and pharmaceutical organizations

The course presents the in-depth, practitioner-level content required to prepare learners to address the com-plex, ever-changing U.S. compliance challenges that companies face. Content includes:

- Foundations of Export Controls

- Jurisdiction & Classification

- Export Authorizations

- Export Clearance

Prac oners2 3 UP TO

200

Duration: Over 14 hours

The course introduces leaders to key compliance issues, shows how training can mitigate corporate risk, and reinforces their role in creating and promoting an effective trade compliance program and culture – essential ingredients for the long-term success of any company.

Execu veLeaders

Duration: Approx. 30 minutes

Sales & Marketing, Human Resources, Engineering, and other employees are key to your company compliance. The course communicates the importance of compli-ance, illustrates key compli-ance issues with role-specific scenarios, and enables users to recognize and respond to potential violations before they occur.

Key RoleProfessionals

Duration: Approx. 60 minutes

Personalize Your Training

Our easy-to-use Curator enables you to

quickly organize and deploy role-based

trade compliance training that includes

embedded company-specific materials to

ensure that your organization's policies

and procedures, messaging, and legacy

training are conveyed, consistently

understood, and adhered to.

Certification

Each learner will receive a Certificate of

Completion from George Mason University's

Schar School of Policy and Government upon

completing any of our trade compliance

practitioner

certificate

program courses.

With Content Enablers, your

training won’t become obsolete

as soon as you’ve completed it.

Learners will have one full year

of access to:

Their role-specific training course

Real-time updates as regulations

change

Live and on-demand access to our

exclusive COMPLIANCE 2021 events

for your PRACTITIONERS, including:

Participation in trade compliance

workshops tailored to the

Medical/Biotech/Pharma sector

Quarterly in-person (and

live-streamed) events at the Schar

School of Policy and Government at

George Mason University

Eight webinars throughout the year

on timely trade compliance topics

TRAINING FOR TRAINING FOR TRAINING FOR

Click for SUBSCRIPTION INFORMATION QUESTIONS or Need to SCALE PACKAGE Up or Down? CONTACT USwww.contentenablers.com/medical-industry/

http://tradecompliance.co/medical-industry-2/

http://tradecompliance.co/contact-us/

https://contentenablers.com/medical-industry/

mailto:[email protected]

Foundations of U.S.Export Compliancefor PractitionersTrade Compliance Practitioner Certificate Course

This practitioner awareness course introduces you to the six primary areas of trade compliance that you may be involved in at your company: jurisdiction and classification, regulated activities, authorizations, authorization management, customs clearance, and trade compliance programs. The course will provide an overview of these areas in relation to the relevant U.S. compliance regimes, including the U.S. Export Administration Regulations (EAR), the International Traffic in Arms Regulations (ITAR), the Foreign Assets Control-administered sanctions and embargoes.

The training identifies key activities and definitions within the trade compliance environment to foster understanding of your role in trade compliance. The course design also permits significant customization options to provide additional company-specific perspective or guide users through corporate compliance procedures.

Target Audience

Employees who are involved – directly or indirectly – in regulated activities should take this course. This includes employees who interact with non-U.S. persons as part of their job. Additionally, employees who are responsible for managing or overseeing personnel who are engaged in trade compliance activities should be considered for this training.

DC | New York | Bangalore

www.tradecompliance.coures & www.contentenablers.com

Learning Objectives

The broadest objective of this course is to enable you to recognize trade-related situations and know how to react in each situation to remain compliant with the trade regulations.

This broad objective is satisfied when you can:

Trade-Specific:

Understand that trade compliance is a company-wide endeavor. Identify your daily activities that give rise to trade compliance considerations. Recall the different regulatory requirements that exist for the identified activities. Distinguish and/or differentiate between the scope, focus, or intent of U.S. regulations. Recognize when to ask for assistance and/or seek guidance. Know that trade controls consider end-use, end-user as well as country of use.

Role-Specific:

Understand that daily activities directly impact or contribute to trade compliance. Recognize that specific training may be required for successful compliance with the different areas of trade compliance. Realize that trade compliance happens at all levels of the company and within all business functions

The Certificate

Upon completion of the course you will receive a certificate from the Schar School of Policyand Government at George Mason University that you can print and automatically add to yourLinkedIn profile.

Welcome and Introduction

Jurisdiction and Classification Determinations

• Overview

• Methods of Classification Determination

• Order of Review o USML o CCL o Specially Designed o Other Considerations

• Documentation and Reassessment

Regulated Activities • Overview

• Key Definitions

• End-User and End-Use Considerations

• Types of Items and Activities

• Internal Activities

• Post-Export Activities

Authorizations • Overview

• ITAR Authorizations o Licenses

▪ Overview ▪ DSP-5 ▪ DSP-61 ▪ DSP-73 ▪ DSP-85 ▪ USML Paragraph (x)

o Part 124 Agreements o ITAR Exemptions o Part 126 Exemptions

• EAR Authorizations o EAR Licenses o EAR License Exceptions

• Submission Portals

• Tips for Submission

Authorization Management • Overview

• Review of Approved Authorizations

• Provisos and Limitations Compliance

• Tracking of Activities Under Authorizations

• Amendments

• Recordkeeping and Reporting

• Best Practices for Authorization Management

Customs Clearance • Overview

• Shipping Documentation

• Electronic Export Information

• Tracking and Decrementation

• Nontraditional Scenarios

• Recordkeeping

Trade Compliance Programs • Overview

• Elements of an Effective Trade Compliance Program

• Topics That Should Be Addressed in a Trade Compliance Program

• Identifying and Disclosing Potential Violations

• Managing Disclosures

• Compliance and Enforcement Actions

• Industry/Peer Best Practices for Trade Compliance Programs

Training Conclusion

Foundations of U.S. Export Compliance for Practitioners

COURSE OUTLINE (Course Duration: Approximately 2 hours 22 minutes)

U.S. Export ��

The practitioner-level training gives learners the foundation for conducting�� !� ��"�!��#��$� � ��# �� $�� !�� %�&��$� �� #�� '��

%��#�� (��) ��%��#��

��

"�� #�#�� "�� *��



��

�� #�� #�� +

��

� %�� !� ��"�!�� !�� #�� !�� %�&�� %�&�� %�� ,�� *�� !�� .�� *��

��

� %�� # �� !�� *�� #�� %�� *��

��

%��#�� &�� &��/�� (#�� (��) ��%��#�� 0��*��

��#�� /��%��#��


• Welcome o Layout of the ITAR o How the EAR Is Structured

Jurisdiction and Classification

Determinations • Overview

• Methods of Classification Determination

o Formal Commodity Jurisdiction Requests

o Commodity Classification Requests

o Encryption CCATS

• Order of Review o United States Munitions List o CCL Scope and Structure o CCL Order of Review o 600 Series o 9x515 Series o Specially Designed o Other Considerations o Triggers, Tips, and Common

Mistakes

• Identification of Technical Data/Technology

o Technical Data (§120.10) o Technology o Marking of Technical

Data/Technology

• Documentation and Reassessment


• Key Definitions o U.S. Person (§120.15) o Foreign Person (§120.16) o U.S. Person o Foreign Person o Export (§120.17)

o Export o Defense Article (§120.6) o Item: Commodities, software

and technology o Defense Service (§120.9)



• ITAR Authorizations o Introduction

• EAR Authorizations o EAR Licenses o §125.4(b)(13)

Authorization Management

• Overview

• Recordkeeping and Reporting


Trade Compliance Programs

• Overview


o What Constitutes a Violation?

o Violations Under the EAR o Penalties for Violations o Sanctions for Violations o Voluntary Self-Disclosures o Notification of Potential ITAR

Violations to the U.S. Government

Training Summary Training Summary

U.S. Export Classification for Practitioners


U.S. Export Authorizationsfor PractitionersTrade Compliance Practitioner Certificate Course

This practitioner-level course examines the authorization types available for exports and imports of regulated hardware, technical information, software and services under both direct commercial sales and foreign military sales program. This course will also address permanent and temporary nature of transactions. This course will provide an overview of these areas in relation to the relevant U.S. compliance regimes, including the Export Administration Regulations, the International Traffic in Arms Regulations and the Foreign Assets Control-administered sanctions and embargoes.

The training provides detailed guidance for implementing the appropriate authorization for transactions which may involve multiple authorization typesas well as different regulations depending on the activity. This course will also discuss which business functions may have the relevant information needed to determine authorization needs such as program management, contracts, business development, procurement and logistics.

Target Audience

Employees who are responsible for determining licensing requirements and obtaining the appropriate authorization. Employees who are responsible for utilizing exemptions and exceptions under the regulations. Employees who play a role in authorization management such as recordkeeping and tracking of activities. Employees who are responsible for managing or overseeing trade compliance activities in other business functions such as classification and export clearance.



Learning Objectives

The broadest objective of this course is to enable learners to recognize the different types of authorizations and their applicability to ensure your transaction is compliant. This broad objective is satisfied when they can:

Trade-Specific:

Understand the implementation requirements for the different types of authorizations under the ITAR and the EAR. Recognize when multiple authorizations are needed for a transaction to be compliant. Identify the authorization management and recordkeeping requirements for the different types of authorization. Remember that different business functions play a role in authorization management and recordkeeping. Distinguish and/or differentiate the requirements between permanent and temporary transactions.

Role-Specific: Understand that they may be responsible for determining the appropriate authorization for a transaction. Recognize that they may be asked to approve the use of a company-certified authorization. Realize that they may be responsible for preparing and submitting formal authorization requests. Understand that they may be responsible for ensuring the appropriate recordkeeping is maintained for an authorization.

The Certificate

Upon completion of the course you will receive a certificate from the Schar School of Policyand Government at George Mason University that you can print and add to yourLinkedIn profile.


• Welcome o Arms Export Control Act o Layout of the ITAR o Registration o Export Administration Act

and International Emergency Economic Powers Act

o How the EAR Is Structured o Subject to the EAR


• Overview


• Key Definitions o U.S. Person (§120.15) o Foreign Person (§120.16) o U.S. Person o Foreign Person o Export (§120.17) o Export o Defense Article (§120.6) o Item: Commodities, software

and technology o Technical Data (§120.10) o Technology o Defense Service (§120.9) o Reexport and Retransfer

(§120.19 and §120.51) o Reexport o Retransfer o Temporary Import (§120.18) o Temporary Export o Public Domain (§120.11) o Significant Military

Equipment (§120.7) o Empowered Official

(§120.25)

o Subject to the Export Administration Regulations (EAR) (§120.42)

o Transfer o Country Group o Military Commodity o Activities That Are Not

Exports, Reexports, or Transfers

o Activities That Are Not Deemed Reexports

• End-User and End-Use Considerations

o Receipt of Licenses and Eligibility (§120.1(c))

o Interpreting ITAR §126.1(d)/(e )

o General Prohibitions o Embargoed or Sanctioned

Destinations o End-Use and End-User

Controls o Red Flags o Denied Persons o Restrictive Trade Practices

and Boycotts

• Types of Items and Activities


• Post-Export Activities o De Minimis Rule o Foreign-Produced Direct

Product Rule


• ITAR Authorizations o Introduction o DSP-5 Licenses o Introduction o Deemed Export/Foreign

Person Employment

U.S. Export Authorizations for Practitioners PAGE 1 of 3


o Technical Data Licenses o Limited Defense Services

Licenses o Offshore Procurement

Licenses o DSP-73 and DSP-74 o DSP-85 and DSP-119 o USML Paragraph (x) o DSP-94 o Overview o Technical Assistance

Agreements o Manufacturing License

Agreements o Warehouse and Distribution

Agreements o Determining Value for

Agreements o Use of Foreign-Person

Contract Employees o Summary of the

Congressional Certification Requirement

o Dollar Thresholds for Certain Transactions

o Congressional Certification Process and Timelines

o Renotifications to Congress o Special Comprehensive

Export Authorizations for NATO, Australia, Japan, and Sweden

o Brokering Activities o Brokering Definitions o Registration of Brokers o Approval Requirements for

Brokers o Brokering Reports

• EAR Authorizations o EAR Licenses o Determining EAR License

Requirements o Support Documentation

Requirements Under the EAR

o Statement by Ultimate Consignee and Purchaser

o Firearms Convention Import Certificate

o PRC End-User Statement o Hong Kong Import License o Hong Kong Export License o Validated End User o Deemed Exports and

Reexports o License Exceptions o Routed Export Transaction

• Submission Portals

• Exemptions o Introduction

Authorization Management • Overview

• Review of Approved Authorizations

• Provisos and Limitations Compliance


• Amendments o DSP Amendments o Amending Agreements

• Recordkeeping and Reporting o ITAR Recordkeeping

Requirements o Defense Articles, Technical

Data, and Defense Services Exports Using Exemptions

o Certification Requirements for Exemptions

o Reporting of Export Information on Technical Data and Defense Services

o Post-Approval Requirements for Agreements

o Introduction o Export Control Document





• Elements of an Effective Trade Compliance Program

• Topics That Should Be Addressed in a Trade Compliance Program



o Violations Under the EAR o Penalties for Violations o Sanctions for Violations o Notification of Potential ITAR

Violations to the U.S. Government

o Voluntary Self-Disclosures

• Managing Disclosures o Identifying When a

Disclosure Should be Made Under the ITAR

• Compliance and Enforcement Actions

o Debarment from Exporting

Training Summary



U.S. Export Clearancefor Practitioners��

This practitioner-level course introduces learners to the regulatory requirements for effecting the actual shipment or transfer of export-controlled items. These activities are commonly called customs clearance. This course will provide an overview of these areas in relation to the relevant U.S. compliance regimes, �� Regulations, the Federal Trade Regulations, and Customs and Border Protection regulations. These activities include preparation of customs clearance ��!�this course will identify the different requirements for hardware and technical information under the ITAR and the EAR as well as the submission methods to CBP. This course will also discuss the different requirements for permanent transactions and temporary transactions. Transactions involving hand-carry scenarios, self-decrementation, domestic transactions with foreign persons and shipments using government transport will also be discussed. Most importantly this course discusses best practices for conducting customs activities.

Target Audience

Employees who are responsible for preparing and reviewing export control documents for customs purposes. Employees who are responsible for clearing inbound items for either a permanent or temporary transaction. Employees who interface with freight forwarders and logistics providers – both domestically and abroad.



Learning Objectives

The broadest objective of this course is to enable learners to recognize the expected steps in clearing items for shipment or transfer and to identify the responsible business functions. ��"��"#��$��%��&

��

Understand the customs clearance requirements for hardware shipments and technical information transfers. ��!��$�� Remember that an authorization requires decrementation to ensure compliance. Recognize the recordkeeping and reporting requirements for the use of exemptions and exceptions. Distinguish and/or differentiate between the different requirements for permanent and temporary transactions. Know that maintaining records associated with a shipment or transfer is critical to successful compliance.

��

Understand that they may be responsible for preparing or submitting customs clearance documentation. Recognize that they may be responsible for decrementing or monitoring an authorization for available quantity or value. Understand that they may be responsible for ensuring the appropriate recordkeeping is maintained related to customs clearance.

��

Upon completion of the course you will receive a ��'��!and Government at George Mason University that you can print and add to your(��

u will receive a��'��! University r


• Welcome


• Overview


• Key Definitions o U.S. Person (§120.15) o Foreign Person (§120.16) o U.S. Person o Foreign Person o Export (§120.17) o Export o Temporary Import (§120.18) o Temporary Export o Red Flags


Authorizations

• Overview

• ITAR Authorizations o Introduction o DSP-73 and DSP-74 o DSP-94 o Subsection 123.4(a)

• EAR Authorizations o EAR Licenses

Authorization Management

• Overview


• Amendments

• Recordkeeping and Reporting o Export Control Document


• Shipping Documentation

• Electronic Export Information

• Tracking and Decrementation

• Nontraditional Scenarios

• Recordkeeping




o Violations Under the EAR o Penalties for Violations o Sanctions for Violations

Training Summary

U.S. Export Clearance for Practitioners

COURSE OUTLINE (Course Duration: Approximately 1 hour 44 minutes)

TRADE COMPLIANCE FOR Executive LeadershipMEDICAL / BIOTECH / PHARMA

To whom can I export?What can I export?How can I export compliantly?

These three questions are the framework for CE’s Trade Compliance for Executive Leadership training. The course communicates how executive leaders in the Medical Indus-try need to view export, import, corruption, and sanctions and embargoes training as an integrated program to mitigate corporate risk. It discusses key trade concepts relevant to typical business transactions and helps senior leaders understand the critical role they play in promoting and ensuring an effective trade compliance program and culture – essential ingredients for the long-term success of any company.

Target Audience & Learning Objectives

U.S. and non-U.S. Executives

Vice Presidents

Senior Managers

Directors

This concise training for the Medical Industry will help executives, regardless of geographic location, understand their role in trade activities being undertaken by their organization, the risks of non-compliance, and their responsibility for developing and promoting an effective trade compliance program and culture.


The Changing Landscape: Integrated

Trade Compliance

The “Who,” “What,” and “How” of Trade

Compliance

- Overview

- With Whom Is the Trade Conducted?

- What Is Being Traded?

How Is the Trade Conducted?

Your Responsibility

Training Summary

COURSE OUTLINE (approximaely 30 mins.)

TRADE COMPLIANCE OVERVIEW for Key Role ProfessionalsMEDICAL / BIOTECH / PHARMA

UNIQUE TRACKS FOR:

Engineers, HR, Business Development & General Employees

WHO are you doing business with? WHAT is the subject of your transaction? HOW is your transaction being conducted?

CE’s awareness-level Trade Compliance Overview for Professionals in the Medical Industry introduces your key role employees subject to U.S. trade controls to these common themes of the trade process. The course is presented in clear, easy-to-understand microlearning elements that highlight key compliance concepts relevant to international trade and offers engaging scenarios specific to four unique roles and responsibilities that illustrate how these concepts can impact day-to-day situations.

Human Resources

Engineering

Marketing & Business Development

General Employees

This concise training for Medical Industry employees will enable learners to recognize situations that could give rise to the risk of a trade compliance violation and know how to respond in accordance with applicable laws and company policies. Depending on role, training ranges from 46 - 65 minutes.

Target Audience & Learning Objectives

4 Unique Medical Industry Training Tracks for:

dynamic, current, and comprehensive functional trade

Documents