Category: videos

Serialization Implementation kickoff with rfxcel 

Learn more about rfxcel’s serialization implementation kickoff plan and how we structure our kick offs:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

In this segment of the interview Rose explains how our kick off is structured.

Each kick off is structured based on the needs of the organization with which we are partnering, depending on where they are in their serialization program, especially depending on the organization’s prior experience and how familiar they are with the supply chain and serialization process.

“We tailor those discussions so they could be anywhere from a day where we’re in in the morning and we’re out again at the end of the day. Or, it could be up to two and a half days depending on what we need to cover and how many partners they have, and what their business model is,” says Rose.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have discussed our Plan in seven segments:

1. Serialization Implementation Plan based on Audit Needs
2. Boost Serialization Implementation with a Global Team
3. Global Serialization Implementation Team for Global Customers
4. A Serialization Solution Provider Focused on the Long Term Relationship
5. Common Challenges in Serialization Implementations
6. Implementation kick off with rfxcel
7. Switching Serialization Providers

A Serialization Solution Provider Focused on the Long Term Relationship, Customer Success

Learn more about rfxcel’s serialization implementation plan and how we are focused on the long term relationship with our clients:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

Rose and Herb talk about the qualities of rfxcel Serialization Implementation Team focused on the long term relationship with our clients.

Rose started her career in the IT sector which gives her the vantage point. She understands that customers, especially those in the pharmaceutical space, are often given people who don’t understand their industry. This is not the case with our team. We understand the importance of validation and we understand what it means to you to get it right.

We at rfxcel want our customers to know that we have a tremendous amount of integrity in what we do and that we are here to support you in every step of the process, during the time you are using our services. We will be at your disposal, offering help and support, and partnering with you during and after the software installation process.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have discussed our Plan in 7 segments:

1. Serialization Implementation Plan based on Audit Needs
2. Serialization Implementation Team from Start to Finish
3. Global Serialization Implementation Team for Global Customers
4. A Serialization Solution Provider Focused on the Long Term Relationship
5. Common Challenges in Serialization Implementations
6. Implementation kick off with rfxcel
7. Switching Serialization Providers

Learn more: Implementation Plan 

What happens after a company serializes their products? Is there a value beyond compliance?

Digital health is about making the product, the person and the medical experience a seamless experience. In the long term, value beyond compliance is building the future of healthcare and supply chain with data and analytics. In the short term, from the supply chain perspective, having things individually traceable means you can associate data with that product, you can associate them with temperature, humidity and location. Compliance becomes multi dimensional as it moves through the supply chain. This is a technology fusion in the next coming years. Value beyond compliance in the supply chain means controlling your brand and products in real time, letting data increase efficiency and adding revenue.

Is it true that all serialization solutions provide the same ROI?

A simple and basic system will only serve for a few years but if it cannot adapt with the changes then it is a bad investment. The more intelligent pharmaceutical companies are thinking ahead. They ask about the extensibility of the product, where is the long term validation, how to manage this through the lifecycle.  This type of serialization software takes things way past compliance placed by the Falsified Medicines Directive (FMD) in Europe and the Drug Supply Chain Security Act (DSCSA) in the United States. There is a return on investment that can be obtained from a platform for serialization over the long haul.

If companies look at a serialization software as a compliance problem, the only result is compliance and will spend the minimum possible to get there.  Instead, a company should ask, how can a system build add value the more we use it? With this mindset companies can work with serialization software providers to start to do things early and get to that goal. The more sophisticated serialization and compliance systems are the will enable customers to accomplish these goals and effectively manage a supply chain.

About Glenn Abood: Abood is the CEO and founder of rfxcel. He has been providing track and trace solutions for the Pharmaceutical industry in US, Europe, India, Brazil for over 13 years. Glenn focuses on building a company with industry leaders and experts including, Mark Davison.

About Mark Davison: Davison is a serialization and track and trace expert in the European market with over 15 years’ experience bringing solutions to the Pharmaceutical industry.

How can L4L5 solution vendors help customers get ready for the Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act (DSCSA)?

L4L5 solution vendors have to be quick and have the ability to make services available for early rollout. Too many times, in this industry we have made engineering tools fantastic, but they are difficult to implement. Tools need to be at the consumer level, simple. The tools have to be intuitive, simple and quick to implement. Easy to validation is key. The Pharmaceutical industry is validation heavy. If a solution vendors system can’t validate, then things can go wrong and disrupt ones supply chain. L4L5 solution vendors need to make it as easy as possible and ideally give an added value. It is such a new concept.

If a European Pharmaceutical Manufacturer buys a L4L5 solution vendor for Europe, does that mean they need to purchase other L4L5 solution vendors to fulfil other global compliance regulations?

Many solution vendors are only compliant for very limited geographical areas. Experience solution vendors know what they are doing, have experience with different modules and geographies. And as a pharmaceutical company expands, solution vendors can adapt. L4L5 solution vendors should provide an upgrade to fit customer needs at any point. It is important to pick a solution vendors that can fit your compliance needs now and in the future. An experienced L4L5 solution vendors will consider customers goals for the future. It is important that companies in the supply chain pick L4L5 solution vendors that will help reach those goals from the beginning.

About Glenn Abood: Abood is the CEO and founder of rfxcel. He has been providing track and trace solutions for the Pharmaceutical industry in US, Europe, India, Brazil for over 13 years. Glenn focuses on building a company with industry leaders and experts including, Mark Davison.

About Mark Davison: Davison is a serialization and track and trace expert in the European market with over 15 years’ experience bringing solutions to the Pharmaceutical industry.

What do European Pharmaceutical companies need to do in meeting compliance requirements in the United States?

They key is to purchase a system that enables the company to pass data on to the regulators in the most accurate and efficient way possible.  All companies in the supply chain have the obligation to report the data to the authority.  Authorities like the Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act in the United States are providing guidelines on meeting compliance requirements.

Companies need to plan ahead and ask providers how they will pass correct data in a way that is consistent, high quality and validated. This is a fundamental change in the way the drug industry currently does business and is crucial in meeting compliance requirements. Before, all things that were manufactured physical objects and in the same a batch. Tomorrow there will be objects are physical but also virtual. Requiring each package to match the data in the box and each pack along the production line is different.

What do small companies and virtual manufacturers need to do to prepare?

They need to think about, what resources they will need to get this done. How much bandwidth do they have internally to get this done? When choosing a provider, they need to think about what is my side of the deal. Do I have to employ a project manager? How long will this implementation take and how much will they have to invest in serialization?  The compliance allegation is nonnegotiable, they have to get it done as required by Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act (DSCSA).  It is tricky and complicated challenge but there are dedicated experts to get it done

Big drug companies have teams of people with serialization in their job title, however, some small drug companies, have a one-person team, usually the head of manufacturing. These people wear 15 different hats, they don’t have the time to to get the job done because it is such a complicated process, it would totally consume them.

With rfxcel companies in the pharmaceutical supply chain are meeting compliance requirements in 60 business days. That is a big difference between service providers that stretch it for 5 or 6 months. At rfxcel, we like to take the burden away from the customer and actually help with data validation, data management, managing the training partners and designating teams for meeting compliance requirements. Other providers require them to really get their hands dirty and really get into this which requires companies to allocate more time and resources.

About Glenn Abood: Abood is the CEO and founder of rfxcel. He has been providing track and trace solutions for the Pharmaceutical industry in US, Europe, India, Brazil for over 13 years. Glenn focuses on building a company with industry leaders and experts including, Mark Davison.

About Mark Davison: Davison is a serialization and track and trace expert in the European market with over 15 years experience bringing solutions to the Pharmaceutical industry.

Falsified Medicine Directive deadlines are putting pressure on the industry. How to get over the EMVO hurdles and how the member states get over those hurdles?

Big system changes are challenging, especially during the beginning stages. The EMVO is doing a great job of getting their side of the framework. It ultimately comes  down to solution providers like rfxcel and others to help the manufacturer’s do their piece of the bargain. This process is not going to be easy, but it needs to happen for patient safety. The underlying theme of the Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act (DSCSA) is patient safety. The end result will enable drug companies keep their product safe by tracing it. All of it is possible. It is just a matter of allocating the right resources and people who will prioritize the effort.

The  US has delayed enforcement for a year for DSCSA how does this impact the FMD?

One can never rule out that a delay or postponement will come because it is always possible. However, experts are not convinced there would be an enforcement delay. A deadline is a deadline. Management needs to take action regardless of there being a delay or not.

The reason there is a delay in the US is that Pharmaceutical companies had a difficulty getting the job done in the time available. This indicates to all of the EU that they should not underestimate the difficulty of the project. The real problem here is serialization isn’t just a manufacturing challenge. It is not printing numbers on bottles. It is a business change program across the whole corporation, and supply chain. When companies implement serialization all departments need to get involved in the project. They have to do a lot of work and a lot of internal coordination to get it done.

About Glenn Abood: Abood is the CEO and founder of rfxcel. He has been providing track and trace solutions for the Pharmaceutical industry in US, Europe, India, Brazil  for over 13 years. Glenn focuses on building a company with industry leaders and experts  including, Mark Davison.

About Mark Davison: Davison is a serialization and track and trace expert in the European market with over 15 years experience bringing solutions to the Pharmaceutical industry.