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DSCSA classroom training

DSCSA TRAINING 301 | DSCSA IMPLEMENTATION

This training is essential for the 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 this training, 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-class-room training at the LSPediA’s Michigan Office located in 6230 Orchard Lake Road, West Bloomfield, MI 48302. For travel information, please click Travel Guide. This is a full day class starting at 9am. The cost is $2,000.00.

CLASS & COST

301 DSCSA Implementation $2,000.00

EXPECTED OUTCOME

  • Learn how to implement DSCSA information systems
  • Master the inbound and outbound product tracing transactions
  • Manage ASN, EPCIS, VRS effectively
  • Use APIs to integrate with ERP/WMS

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:

You can take each class individually without prerequisites.

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

Networking breakfast

9:00am

Terminologies and supply chain day-in-life

9:45am

Master Data

  • Product master data
  • Trading partner master data

11:30am

Use APIs to integrate master data with ERP/WMS

12:00pm

Networking lunch

1:00pm

Product Verification

  • Saleable returns verification
  • Suspect product verification
  • History, investigation, and record keeping
  • Product disposition

1:50pm

Use APIs to integrate verification with ERP’s RMA

2:15pm

EPCIS and Edge

  • Inbound EPCIS processing
  • Receiving and put-away serialized products
  • Pick, pack, ship serialized products
  • Process outbound EPCIS

3:15pm

Use APIs to integrate EPC data with ERP/WMS

4:00pm

DSCSA Architecture

  • Overview of L1, L2, L3, L4, L5 systems
  • How to make serialization work by trading partner type (WDD, MFG, Dispensers)

4:45pm

Scanning Barcodes on Pharmaceutical Products

5:00pm

Class completion certificate

6:00pm

Networking reception

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