Learn DSCSA requirements, workflows, and solutions from expert principal instructors. Gain an enhanced understanding of DSCSA regulation including serialized packaging, labeling, product tracing, product verification, and more.
In-class training is hosted at the LSPediA’s Michigan Office located in 6230 Orchard Lake Road, West Bloomfield, MI 48302. For travel information, please click here. Courses are also available remote via the web link after your registration.
Attendees are assigned to projects that assemble real-world DSCSA operational issues. Work individually and in teams to complete hands-on excercises.
To maximize the learning experience, each course has limited seats available.
Our experienced trainers will provide you with a deep understanding of the DSCSA requirements and guide you through the implementation process. You will learn about compliance deadlines and timelines, serialization and product tracing, EPCIS, authorized trading partners, verification systems, and best practices for compliance.
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.
Not a DSCSA expert? No problem, we'll teach you the knowledge and skills you need to work in an FDA regulated environment.
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.
Gain a broader perspective and insight into your trading partners' supply chain operations and requirements under DSCSA.
Gain exposure to the best industry practices and tools available to improve your DSCSA operations.
Our DSCSA training curriculum for dispensers consists of 6 modules that cover all essential aspects of the Drug Supply Chain Security Act,
An introduction to the Drug Supply Chain Security Act, requirements for dispensers, compliance deadlines and timelines.
Understanding DSCSA serialization requirements, the role of product tracing in the supply chain, and implementation of the FDA's electronic tracking system.
EPCIS defined, the transition from lot tracing (TI, TH, and TS) to serial tracing (TI and TS), requirements for EPCIS exchange, global location number (GLN), serialized GLN (sGLN), and tips for efficiently and accurately maintaining records.
Definitions and roles of authorized trading partners, requirements for verification systems, and importance of compliance with verification systems.
Identification of suspect and illegitimate products, DSCSA requirements for handling suspect and illegitimate products, and importance of reporting suspect and illegitimate products.
Tips for ensuring compliance with DSCSA dispenser requirements, common pitfalls and how to avoid them, and importance of ongoing education.
User registration, company and user profile configuration, supplier registration, purchase orders and EPCIS data, scanning and receiving, identifying errors and discrepancies, supplier communication, FDA audits, and 3911 reporting.
Recap of key concepts and requirements, question and answer session, review of next steps for implementation and compliance.
Available in-class and virtually. Space is limited, book today! In-class training is hosted at the LSPedia office located at 6230 Orchard Lake Road, West Bloomfield, MI 48302.
Available in-class and virtually. Space is limited, book today! In-class training is hosted at the LSPedia office located at 6230 Orchard Lake Road, West Bloomfield, MI 48302.
Available in-class and virtually. Space is limited, book today! In-class training is hosted at the LSPedia office located at 6230 Orchard Lake Road, West Bloomfield, MI 48302.
Available in-class and virtually. Space is limited, book today! In-class training is hosted at the LSPedia office located at 6230 Orchard Lake Road, West Bloomfield, MI 48302.
Available in-class and virtually. Space is limited, book today! In-class training is hosted at the LSPedia office located at 6230 Orchard Lake Road, West Bloomfield, MI 48302.
Available in-class and virtually. Space is limited, book today! In-class training is hosted at the LSPedia office located at 6230 Orchard Lake Road, West Bloomfield, MI 48302.
