Master DSCSA Compliance

DSCSA Training Series

LSPedia's Monthly Two-Day Training Program

LSPedia offers essential Drug Supply Chain Security Act (DSCSA) training courses for pharmaceutical professionals working in FDA-regulated environments. DSCSA is the most complex regulation to date 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.

Each course can be taken individually, without prerequisites. We encourage you to take both to develop a comprehensive understanding of DSCSA's requirements, standards, operational workflows, and software solutions.

Training Highlights

DSCSA Regulations & Standards

Learn the complex DSCSA standards and regulations, taught in digestible modules that are easy to understand.

Audit Preparation

Become fully prepared for spontaneous audits from the FDA, NABP, and state regulators.

Supply Chain Management

Acquire the knowledge of supply chain management under FDA's DSCSA requirement.

Verification Exceptions

Gain an in-depth understanding of verification exceptions and workflow best practices.

Investigator

Master all Investigator functionalities and become a certified expert.

Exceptions Management

Learn how to properly manage VRS and EPCIS exceptions.

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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.

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Course Benefits

DSCSA is complex and comprehensive. Most people have limited or little exposure to the DSCSA requirements and applications in its entirety. Attend the DSCSA Courses for the following benefits.

Expert Instructors

Not a DSCSA expert? No problem, we'll teach you the knowledge and skills you need to work in an FDA regulated environment.

Easily Digestible

The DSCSA regulation is complicated. We break it down to digestible bites so you can keep up with the latest requirements, standards, and all future changes/updates.

Supply Chain Transparency

Gain a broader perspective and insight into your trading partners' supply chain operations and requirements under DSCSA.

Operations Efficiency

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

Available in-class and virtually

LSPedia hosts in-person training at its Michigan headquarters: 31555 W 14 Mile Rd, Suite 110, Farmington Hills, MI 48334. Use the "Travel Guide" below on this page for more information on the location, hotels, airlines, and car rental.  

To attend virtually, just use the link you receive after registration.