Live Webinar Customs and Trade Partnership Against Terrorism (C-TPAT) Compliance

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Hear By Carolyn Troiano industry reviewer for 21 CFR Part 11, the FDA’s (ER/ES) regulation. along with computer system validation and risk management/compliance at a number of Fortune 100 firms. "

C-TPAT program overview including “Tiered” strategy

Description

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.
In this webinar, we will provide an overview of the Customs and Trade Partnership Against Terrorism:
• C-TPAT program overview including “Tiered” strategy
• Program guidelines and highlights
• C-TPAT compliance

Why should you attend :

The attendee will learn how to develop a standard approach to complying with the voluntary C-TPAT guidelines.
In this webinar, we will provide an overview of the Customs and Trade Partnership Against Terrorism:
• Understanding of the C-TPAT program, compliance and benefits of joining the program
• Industry best practices related to C-TPAT compliance
• Strategies for reducing the cost and complexity of compliance with C-TPAT

Areas Covered

The course 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.
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.

Who will Benefit

• All companies involved in activities related to shipping and supply chain management of goods (internationally)
• Security professionals working in manufacturing, quality, distribution, warehouse and shipping
• Supply Chain professionals and management
• IT professionals and management
• Auditors engaged in the internal inspection of goods, documentation and practices
• Consultants working in these industries who are responsible for assisting companies with C-TPAT compliance

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Carolyn Troiano

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA’s electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.

Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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