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TRAINING AGENDA

Wednesday

Class 101 – DSCSA Explained

8:30am

Network and breakfast

9:00am

Set up 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

  • Understand EPCIS
  • EPCIS in the operation workflow

11:15am

FDA’s Verification System requirement

  • Suspect Product Investigation
  • Product Verification
  • Saleable returns verification

11:45am

Class completion certificate

Wednesday

Class 201 – DSCSA Exceptions Management

12:00pm

Networking and lunch

1:00pm

Set up and introductions

1:15pm

Verification and exceptions

  • Understand verification exception types
  • Managing exceptions in the daily operations
  • Exception tracking, logging, and record keeping
  • FDA 3911 filing

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

Exceptions Process Analysis

  • SOPs
  • Process variability, repeatability, and reproducible
  • Audit check list

4:30pm

Exception management architecture

  • Procedures
  • Business systems
  • Accountabilities

5:00pm

Class completion certificate

6:00pm

Networking reception

Thursday

Class 301 – DSCSA Implementation

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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