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DSCSA TRAINING 101 & 201 | DSCSA EXPLAINED & EXCEPTIONS MANAGEMENT

Class 101 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.

Class 201 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 & COST

101 & 201 DSCSA Explained & Exceptions Management $2,000.00

EXPECTED OUTCOME

  • 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.

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

11:00am

FDA’s Verification System requirement

  • Suspect Product Investigation
  • Product Verification
  • Saleable returns verification

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

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