Fast Track to Serialization Compliance
Scheduled for November 2017, the U.S. serialization compliance deadline is now just around the corner. Whether they are located in Europe, Asia, or the Americas, CMOs and pharmaceutical companies shipping prescription drugs to the United States must implement serialization programs in order to comply with FDA legislations.
Since there are only a few months left before the law is enforced, CMOs that have not yet implemented serialization processes on their packaging lines must act quickly. This webinar aims to present off-the-shelf products, which were specifically designed for those who haven't started their project or are finding themselves behind schedule. These units are one of the few remaining avenues to meet the deadline, as it is unfortunately no longer possible to deliver custom solutions in time for November 2017.
This informative webinar will explain
- Why the timeline is so short for CMOs who are just starting their serialization project, and what legal and financial impacts await their business if they don’t take action soon.
- How to become serialization-compliant, despite the fast-approaching deadlines and complex implementation steps.
- What to do to maximize remaining time, including the sums to invest and the steps to prioritize.
The main conclusion of this webinar will be the demonstration that 95% of the amount invested in these preconfigured units─which include the hardware, cameras, touchscreens, and computers─ can be transferred to an automated packaging line and integrated within a full-fledged custom solution later on. The unequivocal benefit of these new off-the-shelf products is that they enable CMOs to become serialization-compliant by the November deadline, while allowing customization steps to resume once supply activities have returned to their normal pace.
Yanik Beaulieu, Product Line Manager, Optel Vision
Yanik Beaulieu has been with Optel for a total of 8 years, holding various positions in project management, PMO supervision, solution design and, more recently, product line management. Through this valuable experience, he has gained in-depth knowledge of the pharmaceutical industry and customer needs, as his roles have combined the technical aspect, implementation, as well as the business aspect, allowing him to provide excellent insight into the serialization process. Yanik Beaulieu holds a college diploma in Electrical Engineering Technology as well as PMP certification.
Jim Chrzan, Vice president, Brand Development at Healthcare Packaging
In his role as Vice President, Brand Development for PMMI Media Group, Mr. Jim Chrzan travels the U.S. and Europe tracking developments in life sciences regulations, serialization, patient adherence and the temperature-controlled packaging supply chain.