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Photo of staff in LSPediA's DSCSA classroom

DSCSA/Serialization TRAINING Courses

LSPediA training courses are essential to pharmaceutical professionals working in a FDA regulated environment performing various serialization operations under the Drug Supply Chain Security Act (DSCSA) requirement. DSCSA is the most complex regulation to date for pharmaceutical manufacturers, wholesale distributors, and dispensers. Our expert principal instructors will teach you the building blocks of DSCSA including serialized packaging/labeling, product tracing, and product verification. The DSCSA courses are taught in 2 days.

Each course can be taken individually without prerequisites. We encourage you to take both for enhanced understanding of DSCSA regulation, standards, supply chain requirement, operational workflow, and software solutions. For details of the course subjects, please see training schedule.

Available in-class and virtually

In-class training is hosted at the LSPediA’s Michigan Office located in 6230 Orchard Lake Road, West Bloomfield, MI 48302. For travel information, please click here. Courses are also available remote via the web link after your registration.

Benefits

DSCSA is complex and comprehensive. Most people have limited or little exposure to the DSCSA requirements and applications in its entirety. Attend the DSCSA Courses for the following benefits.

  1. Not an expert of DSCSA? No problem, we’ll teach you the knowledge and skill you need to work in an FDA regulated environment.
  2. Regulation too long and hard to read? We’ll break it down to digestable bites so you can keep up with the latest requirements, standards, and the any future changes to stay compliant.
  3. Blind of your trading partners demand? Gain broader perspective and insight of your trading partners’ supply chain operations under the DSCSA requirement
  4. Out dated process and old habits? Gain exposure to best practices and tools available to improve your DSCSA operations

Training Schedule

Class syllabus will be provided after your registration. Space is limited, register today.

101 DSCSA Explained & 201 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 FDA’s DSCSA requirement
  • Understand Verification Exceptions and workflow
  • Learn EPCIS Exceptions and their workflow
  • Master Investigator functionalities
  • Manage VRS and EPCIS exceptions

301 OneScan for DSCSA Implementation

$2,000.00

Expected Outcome

  • Learn how to use OneScan to implement DSCSA
  • Master the inbound and outbound transactions
  • Manage ASN, EPCIS, VRS effectively
  • Use APIs to integrate with ERP/WMS
  • Effectively retrieve product tracing information for business and regulatory audits

Classroom Size

Attendees are assigned to projects that assemble real world DSCSA operational Issue. They work individually and in teams to complete hand-on exercises. For those reasons, each course is limited to 10 students only.

Minimum of three students required to run the training.

Equipment

Please attend the class with a laptop computer. The minimum requirement of the laptop computer is listed below.

  1. has one USB port
  2. has an updated Google Chrome browser
  3. has wireless wifi capability

If you don’t have a laptop, we’ll provide a loaner. Please request your loaner 14 days in advanced. We will provide a 2D scanner for the class activities.

Changes and Cancellations

There is no refund for cancellation. Any missed training will be credited forward future training of your choosing. To request a change, please click here.

“Riya, Just a simple ‘Thank You!’ You and your staff are awesome! Really enjoyed [the] hospitality and professionalism of the staff. I had fun and learned a lot. You guys are awesome! Thanks again, George Lovecchio” (Executive Director, Louisiana State Board of Drug and Device Distributors)