New Classes: DSCSA Explained & Exceptions Management

DSCSA Training 101 & 201 – DSCSA Explained & Exceptions Management

Registration | Book Hotel | Travel Guide

This training is essential for pharmaceutical professionals who are in Regulatory, Compliance, Quality, Operations, Supply Chain, Warehouse, Distribution, Customer Service, and IT functions. If you need your manager’s approval to attend, please click Training Request to download the template that you can submit to your manager for approval.

Dates and Location

These classes are offered as in-classroom training at LSPedia’s Michigan office at 6230 Orchard Lake Road, West Bloomfield, MI 48302. For travel information, please click Travel Guide. This is a full day class. The cost is $2,000.00.

You also have the option to attend your classes remotely via web meeting. For remote learning, use your the meeting link in your registration confirmation.

Training Overview

LSPedia training classes are designed for pharmaceutical professionals working in an FDA regulated environment under the Drug Supply Chain Security Act (DSCSA) requirement. DSCSA is the most complex regulation to date for pharmaceutical manufacturers, wholesale distributors, and dispensers. This training is essential for pharmaceutical professionals to gain the knowledge needed to perform their daily tasks meeting DSCSA compliance. The classes are:

• 101 & 201 DSCSA Explained & Exceptions Management
• 301 DSCSA System Implementation

You can take each class individually without prerequisites. We recommend taking both trainings to enhance your DSCSA implementation knowledge.

Benefits

LSPedia Training Series bring the following benefits.

1. Acquire the knowledge need to work in an FDA regulated environment
2. Keep up with the new regulations, standards, and the latest changes to help your company adhere to compliance
3. Gain broader perspective and insight of supply chain operations under the DSCSA requirement
4. Lean the best practices and tools available to improve your DSCSA operations
5. Meeting cGMP and DSCSA training requirements

Class Syllabus

8:30am Network and breakfast

9:00am Set up and introductions9:15am 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

• Understand EPCIS
• EPCIS in the operation workflow

11:00 FDA’s Verification System requirement

• Suspect Product Investigation
• Product Verification
• Saleable returns verification