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DSCSA Regulations & Standards
Learn the complex DSCSA standards and regulations, taught in digestible modules that are easy to understand.
dscsa • serialization • exceptions
DSCSA Training
Learn DSCSA requirements, workflows, and solutions from expert principal instructors. Gain an enhanced understanding of DSCSA regulations, including serialized packaging, labeling, product tracing, product verification, and more.
Training Series
LSPedia offers essential Drug Supply Chain Security Act (DSCSA) training courses for pharmaceutical professionals working in FDA-regulated environments. DSCSA is the most complex regulation to date for pharmaceutical manufacturers, wholesale distributors, dispensers, and other trading partners; businesses of all sizes need skilled personnel to ensure ongoing compliance with the new law.
Professionals at all levels, and all parts of the pharma supply chain, are welcome at LSPedia's monthly two-day training intensive. Expert instructors provide a complete view of DSCSA compliance, including serialized packaging, product tracing, product verification, exceptions management, and more.
Each course can be taken individually, without prerequisites. We encourage you to take both to develop a comprehensive understanding of DSCSA's requirements, standards, operational workflows, and software solutions.
DSCSA Training Includes
Audit Preparation
Become fully prepared for spontaneous audits from the FDA, NABP, and state regulators.
Supply Chain Management
Acquire the knowledge of supply chain management under FDA's DSCSA requirement.
Verification Exceptions
Gain an in-depth understanding of verification exceptions and workflow best practices.
Investigator
Master all Investigator functionalities and become a certified expert.
Exceptions Management
Learn how to properly manage VRS and EPCIS exceptions.
Available in-class and virtually
LSPedia hosts in-person training at its Michigan headquarters: 31555 W 14 Mile Rd, Suite 110, Farmington Hills, MI 48334. Use the "Travel Guide" below on this page for more information on the location, hotels, airlines, and car rental.
To attend virtually, just use the link you receive after registration.
Course 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.
Expert instructors
Not a DSCSA expert? No problem, we'll teach you the knowledge and skills you need to work in an FDA regulated environment.
Easily digestible
The DSCSA regulation is complicated. We break it down to digestible bites so you can keep up with the latest requirements, standards, and all future changes/updates.
Supply chain transparency
Gain a broader perspective and insight into your trading partners' supply chain operations and requirements under DSCSA.
Operations efficiency
Gain exposure to the best industry practices and tools available to improve your DSCSA operations.
July 12-13, 2023 (8:30am - 5:00pm EST)
Register Now
Available in-class and virtually. Space is limited, book today! In-class training is hosted at the LSPedia office located at 31555 W 14 Mile Rd, Suite 110, Farmington Hills, MI 48334.
August 2-3, 2023 (8:30am - 5:00pm EST)
Register Now
Available in-class and virtually. Space is limited, book today! In-class training is hosted at the LSPedia office located at 31555 W 14 Mile Rd, Suite 110, Farmington Hills, MI 48334.
september 6-7, 2023 (8:30am - 5:00pm EST)
Register Now
Available in-class and virtually. Space is limited, book today! In-class training is hosted at the LSPedia office located at 31555 W 14 Mile Rd, Suite 110, Farmington Hills, MI 48334.
october 4-5, 2023 (8:30am - 5:00pm EST)
Register Now
Available in-class and virtually. Space is limited, book today! In-class training is hosted at the LSPedia office located at 31555 W 14 Mile Rd, Suite 110, Farmington Hills, MI 48334.
DSCSA 101/201 Agenda
09:50 AM
Class arrival and sign in to meeting
10:00 AM
101 Introduction
- Welcome
- Overview of class objectives and agenda
- Welcome
- Overview of class objectives and agenda
10:15 AM
Global regulatory landscape
- Risks to the global supply chain
- Regulations across the globe
- Risks to the global supply chain
- Regulations across the globe
10:30 AM
Prescription safety in the United States
- Risks to the US supply chain
- Patchwork state regulations
- Risks to the US supply chain
- Patchwork state regulations
11:00 AM
Drug Quality Security Act
11:10 AM
DQSA Title II – The Drug Supply Chain Security Act (DSCSA)
- Components
- Timeline
- Components
- Timeline
11:30 AM
DSCSA in practice
- Terminology Overview
- File formats
- Connections
- Verification
- Terminology Overview
- File formats
- Connections
- Verification
12:00 PM
Break for lunch
01:00 PM
201 Introduction
- Welcome back
- Overview of class objectives and agenda
- Welcome back
- Overview of class objectives and agenda
01:15 PM
Recap of DSCSA
- Purpose, scope, and key elements
- Purpose, scope, and key elements
01:30 PM
Authorized Trading Partners (ATPs)
- Overview of authorized trading partner requirements under DSCSA
- Explanation of key terms and concepts related to authorized trading partners
- Overview of authorized trading partner requirements under DSCSA
- Explanation of key terms and concepts related to authorized trading partners
01:45 PM
Product identifier: serialization and aggregation requirements
- Overview of serialization and aggregation requirements under DSCSA
- Explanation of key terms and concepts related to serialization and aggregation
- Detailed explanation of the requirements for product tracing, verification, and reporting, including aggregation at various levels
- Discussion of the impact of serialization and aggregation on the pharmaceutical industry
- Overview of serialization and aggregation requirements under DSCSA
- Explanation of key terms and concepts related to serialization and aggregation
- Detailed explanation of the requirements for product tracing, verification, and reporting, including aggregation at various levels
- Discussion of the impact of serialization and aggregation on the pharmaceutical industry
01:45 PM
Product identifier: serialization and aggregation requirements
- Overview of serialization and aggregation requirements under DSCSA
- Explanation of key terms and concepts related to serialization and aggregation
- Detailed explanation of the requirements for product tracing, verification, and reporting, including aggregation at various levels
- Discussion of the impact of serialization and aggregation on the pharmaceutical industry
- Overview of serialization and aggregation requirements under DSCSA
- Explanation of key terms and concepts related to serialization and aggregation
- Detailed explanation of the requirements for product tracing, verification, and reporting, including aggregation at various levels
- Discussion of the impact of serialization and aggregation on the pharmaceutical industry
02:00 PM
Verification requirements
- Overview of verification requirements under DSCSA
- Explanation of key terms and concepts related to verification
- Overview of verification requirements under DSCSA
- Explanation of key terms and concepts related to verification
02:45 PM
Best practices for compliance
- Overview of best practices for complying with the serialization, aggregation, and interoperability requirements of DSCSA
- Discussion of common implementation challenges and strategies for overcoming them
- Examples of successful compliance approaches and strategies
- Overview of best practices for complying with the serialization, aggregation, and interoperability requirements of DSCSA
- Discussion of common implementation challenges and strategies for overcoming them
- Examples of successful compliance approaches and strategies
02:50 PM
Closing remarks
DSCSA 301/401 Agenda
09:50 AM
Class arrival and sign in to meeting
10:00 AM
301 Introduction
- Welcome
- Overview of class objectives and agenda
- Welcome
- Overview of class objectives and agenda
10:10 AM
Terminologies and supply chain day-in-life
OneScanQA login
OneScanQA login
10:20 AM
Master Data: What is it?
10:40 AM
Set up a new supplier in OneScan
Set up a new product in OneScan
Set up a new product in OneScan
11:00 AM
EPCIS and Edge
- Ship an order to WDD customer
- View outbound EPCIS data file
- View inbound EPCIS
- Scan-in to receive the order
- Ship an order to WDD customer
- View outbound EPCIS data file
- View inbound EPCIS
- Scan-in to receive the order
11:20 AM
APIs for integration:
- Orders API
- Master Data API
- VRS API
- Orders API
- Master Data API
- VRS API
11:40 AM
Use JSON script to retrieve an inbound purchase order
12:00 PM
Break for lunch
01:00 PM
Verify, Verify+, History
01:20 PM
Scanning barcodes on pharmaceutical products
- Dos and don’ts and best practices
- Dos and don’ts and best practices
01:40 PM
Verify products: good, expired, recalled, mismatch, suspect and illegitimate.
- Initiate an Investigation
- Verify+ to quarantine a product
- View the Notification Record, clear a product
- Initiate an Investigation
- Verify+ to quarantine a product
- View the Notification Record, clear a product
01:55 PM
Closing remarks
Travel to LSPedia HQ
Items
Details
Training Location
LSPedia, Inc - 31555 W 14 Mile Rd, Suite 110, Farmington Hills, MI 48334
Airport
DTW (Detroit) - 20 miles from LSPedia HQ
FLT (Flint) - 35 miles from LSPedia HQ
FLT (Flint) - 35 miles from LSPedia HQ
Airlines
Delta Skybonus Number: US0093158
Car Rental
Hertz LSPedia CDP: 2125614
Avis Discount (AWD) #: Y645681
Avis Discount (AWD) #: Y645681
Corporate Hotels
Hampton Inn, Southfield, MI (Book online)
33096 Northwestern Hwy
West Bloomfield, MI 48322
(248) 671-6500
Company Name: LSPedia
Corporate ID: 0003165977
Home2 Suites by Hilton (Book online)
33098 Northwestern Hwy
West Bloomfield, MI 48322
(248) 940-1000
Company Name: LSPedia
Corporate ID: 0003165977
33096 Northwestern Hwy
West Bloomfield, MI 48322
(248) 671-6500
Company Name: LSPedia
Corporate ID: 0003165977
Home2 Suites by Hilton (Book online)
33098 Northwestern Hwy
West Bloomfield, MI 48322
(248) 940-1000
Company Name: LSPedia
Corporate ID: 0003165977
Training FAQ
To access our document on DSCSA training FAQs, please click the link below for instant download.
View & Download PDFHow to Attend the Training: Are participants required to travel so that they can attend the training?
Our training classes are attended by trainees online and trainees on premise. To attend training on premise, here is the travel information www.lspedia.com/about/travel.
What Do I Need to Know Before Attending: Is there any prerequisite knowledge or access required for taking this training?
Prerequisite knowledge is not necessary. Our training is designed to help all practitioners understand DSCSA requirements and learn key terminology, regardless of their experience level. As the trainee moves through the sessions, trainees learn how OneScan is used to ensure compliance and the LSPedia experts help trainees use OneScan as part of their daily routines.
Certification and Accreditation: Upon successful completion of the courses, will participants receive any formal certification or accreditation that can be used for professional development or credentialing purposes?
Trainees who complete the DSCSA training classes receive certification of completion. LSPedia is working with Michigan Pharmacy Association to get the curriculum approved for CE credit in Michigan.
Course Materials: Are there any course materials, such as handbooks, guides, or software tools, that will be provided for future reference and application of the learned concepts in our daily operations?
Trainees are provided electronic copies of the training manual and class handouts. Trainees are given access to the OneScan platform to learn DSCSA operational activities on the training day.
Networking Opportunities: Will there be opportunities for networking with other professionals or experts in the field during the training, which could be beneficial for future collaborations or knowledge sharing?
Trainees benefit by learning from other professionals attending the training, sharing their challenges and best practices. Trainees have access to the cohort attendee contacts for future connections at trainees' discretion.
Post-Course Support: Does LSPedia offer any post-course support or access to resources for attendees to ensure the continued application of DSCSA compliance strategies and best practices?
Trainees can download the recorded training session within 30 days after the training day. Trainees are also provided contact information of LSPedia representatives who can assist the trainees and their company in adopting DSCSA best practice for compliance adherence and operational efficiencies. Monthly 2x Connect Webinar series covers new developments in the space and provides a live Q&A forum to get answers to pressing questions.
Software or Tool Demonstrations: Will the training include hands-on demonstrations or trial access to LSPedia’s software solutions, like OneScan, to better understand their application in real-world scenarios?
Trainees are provided access to the OneScan platform for hands-on exercises within the scope of the training. In aggregate, LSPedia-led training covers the DSCSA requirements and functions of ATP, ASN, EPCIS, Product Tracing, VRS, Product Verification, Exception Management, and 3911 reporting.
Do You Offer Personalized Training: Can a company request to have the training at their location for their team/company?
LSPedia offers personalized training for OneScan customers. The training content can be tailored to the customer's DSCSA process. Please contact your account manager directly or reach out to am@lspedia.com for further discussion.
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OneScan suite is the leading DSCSA solution, designed and proven to increase productivity, profitability, and supply chain visibility. LSPedia's seamless, cloud-based compliance solution streamlines the track and trace requirements with little impact on your daily processes.
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