DSCSA Training

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.

DSCSA | Serialization | Exceptions

TRAINING SERIES

LSPediA training courses are essential to pharmaceutical professionals working in a FDA regulated environment performing various serialization operations under the Drug Supply Chain Security Act (DSCSA) requirement. DSCSA is the most complex regulation to date for pharmaceutical manufacturers, wholesale distributors, and dispensers. Our expert principal instructors will teach you the building blocks of DSCSA including serialized packaging/labeling, product tracing, and product verification. The DSCSA courses are taught in 2 days.

Each course can be taken individually without prerequisites. We encourage you to take both for enhanced understanding of DSCSA regulation, standards, supply chain requirement, operational workflow, and software solutions. For details of the course subjects, please see training schedule.

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.

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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.

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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.

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supply chain transparency

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

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operations efficiency

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

DSCSA 101 & 201

Registration Cost: $2,000
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.

InvestigatorTM

Master all Investigator functionalities and become a certified expert.

Exceptions Management

Learn how to properly manage VRS and EPCIS execptions.

Wednesday, April 05, 2023 (8:30am - 5:00pm EST)

Register Now

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.

Wednesday, june 07, 2023 (8:30am - 5:00pm EST)

Register Now

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.

Wednesday, August 02, 2023 (8:30am - 5:00pm EST)

Register Now

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.

Wednesday, OCTOBER 04, 2023 (8:30am - 5:00pm EST)

Register Now

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.

Wednesday, DECEMBER 06, 2023 (8:30am - 5:00pm EST)

Register Now

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.

DSCSA 101 Agenda

Available in-class or virtually

8:30am
Network and breakfast
9:00am
Setup and introductions
9:15am
DSCSA Title II
• Authorized trading partner
• Product tracing at the lot level (T3)
9:30am
Implement lot level tracing with advanced shipping notice (ASN)
• Understand EDI 856 ASN standard
• ASN in the operational workflow
10:00am
DSCSA Title II
• Product tracing at the package level (serial tracing)
• Interoperability
• Enhanced supply chain security
10:30am
Implementing EPCIS for serial tracing
• Understanding EPCIS
• Enhanced supply chain security
11:15am
FDA's Verification System requirement
• Suspect Product Investigation
• Product Verification
• Saleable returns verification
11:45am
Class completion certificate

DSCSA 201 Agenda

Available in-class or virtually

12:00pm
Networking and lunch
1:00pm
Setup and introductions
12:00pm
Networking and lunch
1:15pm
Verification and exceptions
• Understand verification exception types
• Managing exceptions in the daily operations
• Exception tracking, logging, and record keeping
• FDA 3911 reporting
2:30pm
EPCIS data exchange and exceptions
• Understand EPCIS exception types
• Managing EPCIS exceptions in the daily operations
• EPCIS exception tracking, logging, and corrections
3:30pm
EPCIS data exchange and exceptions
• Understand EPCIS exception types
• Managing EPCIS exceptions in the daily operations
• EPCIS exception tracking, logging, and corrections
• FDA 3911 reporting
4:30pm
Exception management architecture
• Procedures
• Business systems
• Accountabilities
5:00pm
Class completion certificate
5:00pm
Networking reception

Travel to Lspedia hq

Items
Details
Training Location
LSPedia, Inc - 6230 Orchard Lake Road #280, West Bloomfield, MI 48322
Airport
DTW (Detroit) - 20 miles from LSPedia HQ,
FLT (Flint) - 35 miles from LSPedia HQ
Airlines
Delta Skybonus Number: US0093158
Car Rental
Hertz LSPedia CDP: 2125614
Avis Discount (AWD) #: Y645681
Corporate Hotels
Hampton Inn Southfield, MI (33096 Northwestern HWY. West Bloomfield, MI 48322) (248) 671-6500

Company Name: LSPedia
Corporate ID: 0003165977