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Aug. 24, 2022 DSCSA Class 101 & 201 – DSCSA Explained & Exceptions Management

By July 14, 2022August 10th, 2022DSCSA, Event

DSCSA Training 101 & 201 – DSCSA Explained & Exceptions Management

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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. The cost is $2,000.00.

Class & CostAvailable DatesExpected Outcome
101 & 201 DSCSA Explained & Exceptions Management $2,000.00

 

Register

8/24/2022 9am – 5pm

10/5/2022 9am – 5pm

12/7/2022 9am – 5pm

  • Learn DSCSA regulation and industry standards
  • Become prepared for the audits from the FDA, NABP, and State regulators
  • Acquire the knowledge of supply chain management under the DSCSA requirement
  • Understand Verification Exceptions and workflow
  • Learn EPCIS Exceptions and their workflow
  • Master Investigator functionalities

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. 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 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
11:00 FDA’s Verification System requirement

 

  • Suspect Product Investigation
  • Product Verification
  • Saleable returns verification