Master DSCSA Compliance

DSCSA Training Series

LSPedia's Training Program

LSPedia offers essential training courses for pharmaceutical professionals working in FDA-regulated environments. With complex regulation for pharmaceutical manufacturers, wholesale distributors, dispensers, and other trading partners; businesses of all sizes need skilled personnel to ensure ongoing compliance with the new law. Professionals at all levels, and all parts of the pharma supply chain, are welcome.

We encourage you to participate and develop a comprehensive understanding of OneScan and all of the functionality available to subscribers.

Training Highlights

Fundamentals of Track and Trace

The course includes the fundamental principles of Track and Trace including regulatory items, industry standards, serialization, interoperability and other topics.

OneScan User Training

Learn to navigator the various modules within the OneScan platform in a digestible format so that all levels of users can understand

Audit Preparation

Become fully prepared for unannounced audits from federal and/or state regulators

Supply Chain Management

Acquire the knowledge to use the OneScan solution for supply chain management under the new DSCSA regulations

Practical Experience

Dive in and understand the complexities of EPCIS files. Focusing on a hands-on approach, attendees will be able to understand the nuances of EPCIS files and the standards behind the data

There’s more…

Users will get to experience all that OneScan has to offer. The course includes an introduction to all modules in OneScan, providing an understanding of the functionality of each and how they can be used in common workflows

Training Topics

DSCSA Background

Understand DSCSA's role in combating pharmaceutical diversion through product identification, partner authorization, verification, and efficient product tracing to ensure supply chain safety.

Product Tracing - Lot Level w/ ASN

Learn how 3Ts, Advanced Shipping Notice (ASN), and Electronic Data Interchange (EDI) enhance product tracing, ensuring accurate shipment details and compliance.

Product Tracing - Package Level

Master TI and TS data, commissioning and aggregation events, and partner requirements for seamless product transaction information exchange and DSCSA compliance.

Authorized Trading Partner

Explore trading partner roles, ownership transfers, and registration or licensing requirements for authorized partners to ensure regulatory compliance and secure product transactions.

Serial Tracing - GS1’s  Requirements

Understand commission and aggregation events, packaging hierarchies, 2D scanning, pack orders, and EPCIS data for seamless serialization and traceability compliance.

Security & Interoperability

Explore IT, operational, and supply chain impacts of secure, electronic 3T exchanges, verification, and product response, ensuring compliance by November 27, 2023.

Course Benefits

The instructors designed the course for all types of users

OneScan

Become an expert user of the OneScan platform. Designed to be hands-on, attendees will walk away with an understanding of the platforms capabilities and how to use OneScan’s functionality to their benefit

Easily Digestible

Break down the complex industry into digestible chucks and updates on the latest requirements, standards, and future changes.

Operations Efficiency

Gain exposure to the best industry practices and tools available to improve your compliance operations.

Industry Experts

Gather knowledge from subject matter experts in the industry that have experience with various scenarios and have configured solutions that fit within that framework.