Course: Key Elements of Pharmaceutical Serializations and, Track and Trace Systems – Implementation and Compliance Best Practices
Instructor: Terry DeMarco, Implementation Consultant for rfxcel
Duration: 90 min
Boost your knowledge about the pharmaceutical track and trace processes and systems! Learn the fundamentals of serialization, build your plan for implementation, and meet DSCSA compliance requirements.
- 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
- Discuss the ten-year plan to enact serialization and traceability throughout the entire United States supply chain
- Understand what GS1 is and how it is involved in the serialization project
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 certification course on serialization 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
- 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 download the course?
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
