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    • On-Demand Courses/Webinars
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HomeRegulatory & ComplianceKey Elements of Pharmaceutical Serialization and Track & Trace Systems

Key Elements of Pharmaceutical Serialization and Track & Trace Systems

Teachers
Terry DeMarco
Category:
IT & Data Integrity for Pharma/ On-Demand Courses/ Quality/ Regulatory & Compliance/
Clear

— OR —

Duration: 60 minutes
On-Demand
Includes handouts
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

As counterfeit drugs have become more sophisticated, the risk of knock-offs reaching patients increases every year. Naturally, counterfeit drugs can harm brand and profits, but the real victims are patients, who rely on your products to maintain their health, cure illness, or even survive. Therefore, an iron-clad approach to your supply chain is warranted, and required by law. This process of tracing the path of drugs from the manufacturing line to the patient to ensure supply chain integrity is called “Serialization,” and non-compliance is not an option.

Global governments and Health Authorities have introduced laws, issued requirements and provided processes to ensure the sanctity of the pharmaceutical supply chain. In the United States, these requirements were manifested through the Drug Quality and Safety Act (DQSA). This legislation provided the legal requirements and framework by which prescription drugs must be traced through an electronic, interoperable system. Compliance deadlines are looming, and few are ready.

This course will provide you with the critical elements of what is required, and how to approach your specific situation to plan for compliance. Additionally, you will be presented with best practices for implementing/improving your serialization program, and recognize common pitfalls and inspection findings.

LEARNING OBJECTIVES

At the completion of this session, you will:

  • Learn the elements of a best-in-class serialization program, plus the regulatory and patient consequences for having anything short of “the best”
  • Discover how serialization works, and receive context for all the functional areas involved
  • Plan for strategy, implementation, and continuous improvement
  • Outline common failures and regulatory observations you should know and avoid
  • Identify areas for continuous improvement

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone working in a regulated environment on global or domestic scale that manages the product life cycle, develops products that fall under serialization, and compliance laws and manage the quality of products.

This includes personnel in:

  • Quality
  • Compliance
  • Serialization
  • Manufacturing
  • Supply Chain
  • IT

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Terry DeMarco
Terry is an implementation consultant for rfxcel whose mission is to provide a reliable track and trace solution for Manufactures, Re-packagers, Wholesale Distributors, and Dispensers.

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Clear

— OR —

Duration: 60 minutes
On-Demand
Includes handouts

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