Pharmaceutical Serialization Regulatory Requirements for the Americas
In this course you will obtain detailed analysis of the latest requirements for serialization and traceability in the USA and the Americas. Additionally, you will gain critical perspective on best-practices for being prepared for future regulatory mandates. In-depth discussion will include compliance concerns specific to the following regions:
- California (and the impact on California e-Pedigree legislation)
- State-specific and federal requirements in the US
- “Rest of Americas,” with specific focus on Argentina, Brazil, Mexico and Columbia
Attendees will also learn electronic product coding compliance with GS1 barcoding standards. The course culminates with other future considerations that can have a significant impact on your business.
This course will be of benefit to anyone involved in serialization or supply chain pedigree on a global or domestic scale. Additionally, those who need to be able to communicate internally with supply chain personnel or vendors responsible for product distribution will find this course extremely beneficial.
Gordon Glass is an experienced subject matter expert from the pharmaceutical industry, recently moving to consulting services. He has specialized in GS1 standards, AIDC (Automatic Identification Data Capture), electronic product coding, pharmaceutical serialization/track & trace, and the implementation of pharmaceutical supply chain process/technology.
In recent years, he coordinated intelligence gathering of global market requirements for electronic product coding, product serialization, and product track & trace (including e-Pedigree for California). Mr. Glass led global design efforts for a global pharmaceutical company devising compliance solutions for serialization and traceability/authentication.
Mr. Glass has a Bachelor’s Degree in Chemistry from Susquehanna University (Selinsgrove, PA).