C-TPAT Compliance : Industry's Best Practices

Pre Recorded

  • 90 minutes

The Customs-Trade Partnership Against Terrorism (C-TPAT) is a voluntary supply chain security program led by U.S. Customs and Border Protection (CBP). It is intended to improve the security of supply chains of private enterprises against the threat of terrorism.

FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how organizational change should be managed.

In this webinar expert speaker Carolyn Troiano will focus on the key aspects of organizational change management, including best practices and principles for handling this key component of project work in an FDA-regulated environment (i.e., the system “touches” product during the manufacturing, testing or distribution of the product, or during any other functional activity). The material will include the various aspects of change management, including planning, execution, assessment and feedback. The result will be a prescriptive approach to helping teams and individuals reach a higher level of acceptance to change. This session will provide an overview of the Customs and Trade Partnership Against Terrorism.


Session Highlights:

  • C-TPAT program overview including “Tiered” strategy

  • Program guidelines and highlights

  • C-TPAT compliance

  • Learn about the role of the U.S. Customs Border Patrol

  • Understand the potential threats of international terrorism to a company’s supply chain

  • Understand how C-TPAT came to fruition

  • Understand the key benefits of C-TPAT certification

  • Learn how to comply with requirements for C-TPAT certification

  • Learn key ways to mitigate the threats of international terrorism

  • Learn how to use technology to combat terrorism while keeping down cost

Why You Should Attend:

This session will aid to manufacturing or freight/shipping company that handles goods distributed globally. The training will help professionals to secure the international supply chain and mitigate the risks associated with illegal activities that support and fund terrorism. Typically, anyone who is involved in securing the supply chain can benefit, whether handling goods physically or having an impact on the supply chain through policies, procedures, legal action or any other means.

This course will also help those in the CBP and related agencies who must understand the best practices suggested to aid in securing their global supply chains.

Who Should Attend:

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GDPs:

  • Pharmaceutical

  • Medical Device

  • Biologicals

  • Tobacco

Personnel in the following roles will benefit:

  • QC/QA Managers and Analysts

  • Clinical Data Managers and Scientists

  • Quality Managers, Chemists and Microbiologists

  • Compliance Managers and Auditors

  • Computer System Validation Specialists

  • Regulatory Affairs Personnel

  • Consultants in the Life Sciences and Tobacco Industries

Ask your question directly from our expert during the Q&A session following the live event.

Carolyn  Troiano

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, computer system validation and large-scale IT system implementation projects. Carolyn participated in the Industry/FDA partnership that developed 21 CFR Part 11, the FDA’s guidance on electronic records and electronic signatures (ER/ES).

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