Adam Runsdorf, President
The pharmaceutical Third Party Logistics industry is undergoing significant change. The way we choose to address these changes is the difference between facing challenges or creating opportunities.
This issue of Advance focuses on our plans to comply with new rules that are part of the Drug Supply Chain and Security Act, or DSCSA. The law, signed in 2014, requires that all prescription drug products down to the smallest saleable unit (SSU) be electronically tracked at every stage within the supply chain. The deadline for 3PL providers including WDSrx to complete the “Track and Trace” requirement is November, 2017. The term used to enable “Track and Trace” capability to the smallest unit is called Serialization. We are working with three firms to complete our serialization strategy by March 2017, well ahead of the deadline date.
WDSrx is investing significant capital to upgrade our systems, equipment and procedures.
The project requires upgrades to warehouse technology, computer systems and packaging and labeling equipment. New Standard Operating Procedures (SOPs) must be written and new training sessions scheduled to comply with the law.
Our ability to pro-actively manage change instills confidence in our existing clients and promotes our business favorably with prospective clients. Every challenge you face can be viewed from several angles. Try turning challenges into opportunities for successful outcomes.
I hope that you enjoy reading Advance.
I wish you and yours a healthy, happy holiday season.
The WDSrx IT Services Department lays the foundation for keeping up with the new DSCSA Regulations. 2016 has been a crucial year of growth. As the industry grows, technology continues to advance at a rapid rate.
“Our goal is to be compliant by the first quarter of 2017,” says Information Technology Manager Carl Ambroise. “We have three main priorities when it comes to DSCSA Compliance. First, we need to keep track of which clients are affected and how far along are they in their own compliance process. We want to know what we can do to help them achieve this more efficiently. Second, what products are affected? Third, all systems and employees involved in receiving, warehousing, packaging, labeling, distribution and returns must be upgraded for DSCSA compliance.”
In order to maximize our efforts and ensure utmost efficiency, WDSrx has added a new IT team member to the family.
Information System Coordinator Gabriel Calderon is located at our Boca Raton, FL Headquarters location and has nine years of IT and Supply Chain related experience. Gabriel recently relocated to South Florida from Arlington, Virginia.
Watch out – he served six years in the Army National Guard and is a black belt in Taekwondo and Kickboxing!
Gabriel’s goals at WDSrx are, “to be part of the team, add value and continue to grow alongside this fast-paced and successful company.”
Reversing the Trend
Along with our IT Services department, the Reverse Logistics department prepares for DSCSA compliance and procedural changes.
According to Reverse Logistics Manager Jason Solomon, “DSCSA will make tracking products through the reverse distribution process easier. With increased traceability we will know exactly where each product has been. Scanning the bar codes on each bottle will provide us with more information at a more efficient rate than ever before.”
Jason also explains, “The reverse logistics process is similar to accepting an inbound shipment in the WDSrx warehouse; however, it demands a visual inspection for possible reuse or destruction of a product.”
The visual inspection is performed by a qualified employee of the department. They must identify any miscounted, opened or damaged products. Each product is then sorted into a designated area. Certain products such as those containing nicotine, warfarin, insulin, inhalers and vaccines or needles become Hazardous Waste and are processed for regulatory compliant destruction.
Maintaining a healthy diet is crucial for top-notch body and brain function. Those that work all day in a warehouse or an office understand how difficult it can be to stay awake and alert all day. We want to perform daily tasks at our fullest potential, so why not use healthy snacks and fluids to help revitalize us?
In the last issue of ADVANCE, Accounting Manager and Health Enthusiast, Daniela Sinatra, discussed some ideas for cutting back on refined sugars. In this issue, you will find some office snack ideas, along with tips for boosting energy and efficiency.
Healthy snacking improves overall health, fights weight gain, regulates mood, boosts brain power and gives you the energy you need to avoid that afternoon urge for a nap.
“Most pre-packaged snacks and meals are over-processed, loaded with preservatives and difficult for our bodies to digest; this leaves us feeling tired. Eating one big meal for lunch has the same effect. I find that I have more energy throughout the work day when I eat a little healthy snack every couple of hours.” – Daniela Sinatra
Most people reach for carbohydrates when we’re feeling tired because they help lift our mood by boosting the brain chemical serotonin. Processed foods like chips and cookies give us a quick high, but it’s followed by a sharp low that causes tiredness and makes it more difficult to concentrate! Good-for-you fruit sugars, honey, low-fat dairy products, whole grains, and many vegetables lift mood and battle fatigue without the roller-coaster effect.
DANIELA’S HEALTHY OFFICE SNACKING IDEAS:
- Fresh fruit or Organic dried fruit (less sugary preservatives)
- Nuts (Almonds, Cashews, Pistachios, Walnuts)
- Caution: avoid nuts roasted in oil or nuts that are overly salted!
- Nut butter and veggies
- Protein Bar
- Fruit Smoothies
We want to hear your feedback – Try packing some small, healthier snack options each day for one week. Tell us if you notice a difference in your energy levels!
Quality Assurance and Regulatory Compliance are an essential function at WDSrx. The new Drug Security Supply Chain Act (DSCSA) regulations will directly affect this portion of the business in several ways.
“SOPs encompass every step of operations in the warehouses and on the packaging and labeling lines. Each SOP contains the purpose, scope, responsibilities, definitions and history of the procedure. SOPs are constantly reviewed and updated to ensure best practices.”
– Erika Salamon, Quality Assurance Manager
Standard Operating Procedures (SOPs) are written instructions that detail each procedure required to maintain operations. These instructions change as regulations change.
DSCSA implementation is about more than serialization and increased traceability. New regulations will require modification of internal processes, training, documentation and more.
“In our SOP, WH-001 Receiving Procedure for Products, we reference DSCSA Guidelines. Once our customers begin using the unique product identifier on their drug products (such as a bar code) we will have to add additional information to this SOP as well as train anyone who works in this area.” – Erika Salamon
The new FDA Regulations began in 2013 and have a plan in place until 2023. Here are a few things that full DSCSA Implementation will achieve by 2023:
- Enable verification of the legitimacy of the drug product identifier down to the package level
- Enhance detection and notification of illegitimate products in the drug supply chain
- Facilitate more efficient recalls of drug products
- Enhance the US FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated or otherwise harmful
WDSrx-posé gets up close and personal with one of our colleagues! Meet one of our newer employees, Kay Campbell.
Kay joined the WDSrx team in June of this year as the Records Administration Coordinator. Kay works in our Boca Raton location; she keeps track of all administrative and accounting documents and keeps them organized. Kay often works closely with our President – assisting him with daily tasks to stay efficient and organized.
Kay was born in Jamaica and raised in London, England. She studied Criminology and Psychology at Middlesex University. At one point, Kay became a Detainee Immigration Officer where she traveled the world and removed illegal immigrants from the United Kingdom. She eventually migrated to the United States in 2013 and decided to move to South Florida.
She loves to read and write inspirational quotes with which she inspires and encourages her colleagues here in the office and in the warehouse.
Kay loves to learn and eventually wants to go back to school to enhance her personal development and her role here at Woodfield Distribution, LLC!
Find some of Kay’s favorite quotes in the image below of her office whiteboard.
Our Marketing and Business Development teams are constantly creating strategies for increased awareness about WDSrx and our DSCSA compliance initiative.
For example, WDSrx launched our brand new website (www.wdsrx.com).
The website features all of our 3PL Integrated Services, Value Added Solutions, 3PL Expertise, Blog Posts, White Papers, Corporate Videos and Upcoming Events. Check it out!
WDSrx attends trade shows and industry events to increase business. The team recently attended the NACDS Total Store Expo, Logipharma, Tracelink Nexus and the HDA Traceability Seminar. Prospective and current clients will connect with us at BioFlorida in December, the GPhA Annual Conference in February, or the HDA Distribution Management Conference and Expo in March!
WDSrx has several new and engaging exhibition displays and promotional items for use at events, as well as advertising campaigns at FiercePharma.com and in pharmaceutical websites around the country.
Social Media Sharing
Most recently released is our Case Study about Cold Chain Logistics. The storage, handling and transport of temperature regulated pharmaceutical products in the U.S.is a growing segment of the industry.
Check out our Twitter page for highlights and live updates when we attend trade shows and events. WDSrx Twitter also features a daily update image of “Bay 9” in our Headquarters warehouse.
Have you seen our Corporate Videos yet? WDSrx displays seven total videos so far: Company Overview, Warehousing and Distribution, Pharmaceutical Reverse Logistics and Regulatory Compliant Product Disposition, 3PL Pharmaceutical Packaging and Labeling, Gateway to the U.S., Physician Messaging and Patient Services, and E-Commerce Solutions.
Pompano Beach, Florida
WDSrx facilities in Pompano Beach, Florida and Sugar Land, Texas have similar capabilities to handle the new DSCSA compliant serialized product.
New storage racks have been assembled filling up our Pompano facility’s warehouse to accommodate the growing amount of products received.
Sugar Land, Texas
A letter from Robert Betts, our Logistics Manager in Texas:
“We are ramping things up here in Sugar Land, Texas for what we anticipate will be a great 2017!
We recently got our official WDSrx building sign installed and we are thrilled with the outcome. We received our DEA Controlled Substance License, as well as our Importer License which has accelerated our operations and allowed for further progression with all of the state licenses. Our walk-in cooler is fully operational and in the final stages of the validation process; which will allow us to begin work with additional customers.
We are growing quickly and very excited to continue this growth.”
HAPPY HOLIDAYS to Everyone WDSrx!