C-TPAT Compliance for FDA-Regulated Industries

Why Should You Attend:

You should attend this training if you have a role in a manufacturing or freight/shipping company that handles goods distributed globally. The training will help you secure the international supply chain and mitigate the risks associated with illegal activities that support and fund terrorism. The webinar covers air, sea, and land transportation.

Those in industries where contraband and counterfeit are common occurrences should attend to learn how to thwart these activities and protect their supply chains. 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 must attend.

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.

The market for counterfeit and contraband, or “pirated” products can be divided into two important areas. The primary market provides consumers with counterfeit and contraband products. These consumers believe they have purchased genuine products. However, these products are often below standard and can result in health and safety risks that range from mild to life-threatening. The secondary market provides consumers with products they believe to be knock-off merchandise offered at bargain prices. They knowingly are buying counterfeit and contraband products.

In either case, contraband and counterfeit products represent several hundred thousand dollars in lost revenue to manufacturers of genuine product, and the profits generated by them is often funneled to groups that fund terrorist activities. Counterfeit and contraband are being produced and consumed in virtually all economies, with Asia emerging as the single largest producing region. In recent years there has been an alarming expansion of the types of products being infringed, from luxury items (such as deluxe watches and designer clothing), to items that have an impact on personal health and safety (such as pharmaceutical products, food and drink, medical equipment, personal care items, toys, tobacco and automotive parts).

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, primarily by disrupting counterfeit and contraband activity.

Becoming a partner in C-TPAT can provide your company with distinct benefits, such as entering “green lanes” during shipping and hastening the process for gaining entry to the US with goods from overseas.

Areas Covered in the Webinar:

• C-TPAT program overview and tier strategy
• Benefits of joining C-TPAT at a variety of levels
• Supply chain management, counterfeit and contraband activities
• Security for supply chain management
• Standard Operating Procedures (SOPs) and Documentation
• Physical and Logical Security
• Access, Authentication and Authorization
• Risk Assessment, Mitigation and Ongoing Management
• Vendor and Partner Management
• Training Program
• Industry Pitfalls and Best Practices

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in companies currently facing the global challenges of counterfeit and contraband operations, which have a negative impact on their revenue and, potentially, on their reputation. The key areas include:

• Supply Chain Management and Analysts
• Quality Assurance Management and Analysts
• Regulatory Affairs Management and Analysts
• Legal Professionals in Manufacturing Companies
• Information Technology Managers and Analysts
• Compliance Managers and Analysts
• Business Stakeholders responsible for manufacturing supply chain functions
• Consultants working in the manufacturing/supply chain sectors of industry
• Transportation and logistics personnel who are handling goods and supervisors
• Security personnel responsible for supply chain activities
• Auditors and Inspectors responsible for evaluating supply chain security and compliance

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs will highly benefit from this program.

• Pharmaceutical
• Medical Device
• Biologicals
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries

Carolyn Troiano
ERP Project Manager, City of Richmond

Carolyn Troiano has more than 30 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs.

Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

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