Seeing the world through the eyes of a child is a marvelous thing. A child looks at their surroundings through the lens of imagination. It is easy to tell that they see things in a different way. At RemTech, we encourage our consultants to look for new and innovative ways to achieve solutions. Through professional insight, engaging education, and innovative problem solving, RemTech is changing the way we look at the pharmaceutical industry.

Professional Insight

At RemTech, our consultants have years of hands-on experience in industries that include pharmaceutical, engineering, manufacturing, and many more. This experience gives our consultants the ability to analyze your organization’s specific situation and goals, and create a plan that fits your needs. With each project we complete, we add to our knowledge base. And with an ever-growing network of consultants and engineers, we are consistently improving our ability to serve our clients.

Engaging Education

As a company, we strive to push the boundaries of the pharmaceutical and engineering industries. We do this in part by supporting education. One of our Principals, Bob Matje, has worked closely with the International Society for Pharmaceutical Engineering (ISPE) throughout the years. The International Society for Pharmaceutical Engineering is a not-for-profit association that provides its members with scientific, technical, and regulatory leadership throughout the pharmaceutical industry.

Bob also serves as a member of the UGA Pharmaceutical Sciences Advisory Board at the University of Georgia, Atlanta campus. The purpose of this board is to review the current college curriculum to ensure it is in line with current technology and industry needs.

Innovative Problem Solving

An important thing to remember is that RemTech consultants are people. Each of our consultants has a unique personality and background that shape the way they approach problem-solving. Also, each consultant has the backing of the entire RemTech team. Through individual experiences and support from their team, RemTech consultants can tackle any issue and find a solution that fits your unique needs.

RemTech consultants have a unique way of approaching problem-solving. Each consultant brings their own experience and knowledge to the task while also having the backup of the entire RemTech team. We strive to provide our clients with innovative solutions and unparalleled insight that fits their individual needs. Contact us today and let us show you the RemTech Difference.

In the world of pharmaceutical manufacturing, maintaining authenticity and reducing loss are vitally important. A manufacturer has to be able to verify that a product is the correct item and maintain where that product has been and where it is going. Combating counterfeits and theft while providing safe and effective products can be quite a task. Luckily, manufacturers have two tools that can change the game, Serialization and Track and Trace.

Serialization

The serialization process assigns an alpha-numeric code to sealed and verified units. These codes are used to ensure the authenticity of the contents of each unit. By pairing serialization with track and trace processes, manufacturers can help to reduce counterfeit products. When a product is serialized, it becomes harder to produce fake copies of that product. Serialization also aids in product recalls. If there is a problem with an item, then the manufacturer can recall specific serial numbers instead of entire batches or shipments.

Track and Trace

The second tool in a manufacturer’s belt is the track and trace process. The goal of Track and Trace is to track a product throughout the manufacturing process, from the source to the consumer. This process ensures that the manufacturer knows where the components come from and can trace their journey through the supply chain. Track and Trace can also assist in product recalls by identifying where the recalled items have been distributed.

Serialization and Track and Trace are important parts of the manufacturing process. They help to ensure the authenticity of manufactured goods and work to protect the consumer from counterfeit or harmful components. RemTech specializes in serialization and can help your organization implement these processes. Contact us today to see how we can change the way you manufacture products.

The RemTech Difference: Cultivating a Culture

Spring is right around the corner and many are preparing their gardens, lawns, and flowerbeds for warmer weather. Weeding, pruning, fertilizing, mulching, all in the effort to cultivate a healthy landscape. At RemTech, we strive to cultivate a culture of creativity and ingenuity. Through team support and a dedication to innovation, RemTech provides an environment where our consultants will not only grow but flourish.

Our team of consultants has experience in a variety of fields and industries. Many of our consultants have a hands-on background in engineering and project management. Each RemTech consultant brings their individual experience to every project they work on and they lend that experience to other consultants. Through teamwork and shared knowledge, our consultants help each other grow personally and professionally.

Teamwork is an important part of the RemTech culture. Another important aspect is our commitment to innovation. We encourage creative problem solving and give our consultants the freedom to work in a way that best serves the client. As leaders in the pharmaceutical industry, we support educational programs and the development of curricula that are beneficial to those entering engineering programs. With this in mind, RemTech is committed to exceeding expectations and going above and beyond industry standards to provide an exceptional service to our clients.

Like any garden, cultivating a healthy and strong culture takes effort. It takes consultants working together to make a better team. It takes leadership driving and supporting innovation and education in our industry. It takes the knowledge that comes from years of experience. In short, it takes RemTech.

The new year offers many new opportunities. Every January we have the chance to evaluate ourselves and make changes for improvement. We set new goals for our lives, such as physical goals, financial goals, or personal growth goals. While setting personal goals for ourselves is important, it’s equally important to set professional goals for our organizations. RemTech has the experience and knowledge to help you meet and exceed your organizational goals.

Physical Goals

One important aspect of your business is the physical layout and the equipment you use. Whether you need upgraded equipment, a more efficient layout, or you are planning to expand your facility, RemTech has the experience to help you meet those goals. Our consultants are experienced project managers that work as your representative throughout the planning, construction, and/or installation process.

Financial Goals

At RemTech, we want to see your new project or goal succeed. Part of that success is staying within budget while completing the scope within the planned timeline. RemTech consultants work with you to monitor your organization’s processes to find any areas that can be improved. We know manufacturing standards as well as business processes and help companies to streamline those processes.

Personal Growth Goals

RemTech offers staff augmentation to help improve your team. Our consultants work as a member of your team to share our knowledge and experience. We work with our partners to train and lead existing employees on new processes or new equipment. We ensure that have the ability and knowledge to maintain productivity even after we’re gone.

A new year offers many new choices for you and your organization. As you set out to meet your goals for this new year, make the easy choice by partnering with RemTech. Contact us today and let’s put a plan together so you can meet your goals.

RemTech Consultant: David Burgos

It’s always a pleasure to introduce one of the hard-working members of our team. This month, we would like to take the time to spotlight David Burgos. David has been a valuable member of our team of consultants since 2017 and we are excited for you to get to know him better.

David is a Senior Project Manager at RemTech with a background in Pharmaceutical and Packaging Engineering. He puts this experience to work for our clients as a Capital Project Manager. In this role, he works with clients to oversee projects from concept to completion and commercial startup.

In 2000, David graduated from University of Missouri-Columbia by earning his BS in Chemical Engineering. From there, David started his career in the Pharmaceutical industry at Sanofi-Aventis, and has since held contract and full time engineering roles in animal health, contract packaging, consumer products, and medical device industries.

David has years of experience as a project manager, project specification, procurement, overseeing  installation, qualification, and providing training for new equipment and processes for his clients. Recently, David has been working with a global pharmaceutical company managing the production of medical device combination products overseeing long term projects for device assembly, packaging, serialization, and high speed automated visual inspection of injectables .

David is a natural-born problem solver and change agent. When working with clients, he builds relationships, learns their processes and drives stagnant projects across the finish line. He is a focused and driven person and a skilled manager. As a father of four, David is able to put these skills to work even with his youngest “clients.”

At RemTech, David is a valued member of our team. He is one of our many consultants that have the backing of real-world in-plant experience so they can serve our clients’ needs effectively and efficiently. Our consultants have hands-on experience in engineering fields and that’s what makes them different. David is part of the RemTech Difference and he can make a difference for you.

Leading the Way

RemTech is committed to the advancement of education in the pharmaceutical, technology, and engineering industries. As part of that commitment, one of our Principals, Bob Matje, has worked closely with the International Society for Pharmaceutical Engineering (ISPE) throughout the years. Recently, the ISPE has published a new book, APQ Guide: Management Responsibilities & Review (MRR). Bob is a co-author on this guidebook and we are proud of his contribution and dedication to furthering education.

The International Society for Pharmaceutical Engineering is a not-for-profit association that provides for its members in scientific, technical, and regulatory leadership throughout the pharmaceutical industry. With their commitment to education, the ISPE facilitates the exchange of ideas and practical experience. The ISPE is a leader in next-generation technologies and solutions. You can learn more about ISPE and its role in the pharmaceutical industry by visiting here.

In their new guidebook, APQ Guide: Management Responsibilities & Review (MRR), the ISPE outlines the responsibilities of leaders in the communication and demonstration of pharmaceutical system support. The guide also lays out the expectations and evaluation of management as highlighted in ICH Q10. A digital copy of the guidebook can be found here.

Bob Matje and the rest of the team at RemTech are ardent supporters of furthering education. We work with many different organizations and we have our finger on the pulse of the pharmaceutical industry. We know the needs and opportunities in this industry, so we use that knowledge to help shape education so that students and team members can keep pushing the bounds of technology and innovation. At RemTech, we are paving the way for the pharmaceutical industry of tomorrow.

8th Annual UGA/FDA Medical Device Regulation Conference

It’s that time again! The 8th Annual UGA/FDA Medical Device Regulation Conference will be held on September 21-23, 2021. The conference is co-sponsored by the United States Food and Drug Administration and the University of Georgia’s International Biomedical Regulatory Sciences. This conference will be hosted virtually by the University of Georgia’s College of Pharmacy and will focus on quality assurance and regulatory affairs dealing with the medical device industry in the United States.

There will be a broad range of topics discussed at the conference presented by highly experienced professionals from the FDA and medical device industry and consulting firms. Proposed topics for discussion include FDA updates for CDRH and ORA, Remote Regulatory Assessment, International updates, and many others. The educational and networking opportunities provided at this conference will lay the groundwork for the future of medical device regulatory sciences.

Bob Matje, Principal at RemTech, is a member of the UGA Pharmaceutical Sciences Advisory Board at the University of Georgia, Atlanta campus. As a member of this board, Bob works to review the current college curriculum to ensure it is in line with current technology and industry needs. Bob is passionate about education and the future of the medical and pharmaceutical industry. RemTech shares that passion. At RemTech, we are committed to furthering education through conferences and programs like the UGS/FDA Medical Device Regulation Conference. We hope that you will consider being a part of this with us.

Better Together

Peanut butter and jelly, Simon and Garfunkel, rhythm and blues. Some things are just better together. Add one more to the list: RemTech and Triad Unlimited. RemTech has partnered with Triad to bring superior program packages to better serve our clients. Each team brings specialized areas of focus to the table to create a better-equipped partnership to serve you and your organization.

Triad is a professional Asset Management Practitioner Consultancy Firm possessing a portfolio of collective global projects for a multitude of industrial customers. The scope of their products and services are in Life Cycle Asset Management, Maintenance, Reliability Engineering, and Long-Term Capital Planning Analysis in support of Operational Excellence. Triad utilizes their proven Asset Management Framework, cloud-based Learning Management System, and RelialtyicsTM which is their leading-edge proprietary technology for data analytics. Triad approaches every project focused on integrity, extraordinary value, clear communication, and on-time delivery.

Triad’s core services include an Asset Management Gap Analysis and Improvement Plan (AMGAIP) that addresses optimizing Operating Investment for Operational improvement and A State of Good Repair (SGR) Analysis that addresses optimizing Capital Investment. 

Triad’s AMGAIP Technology Tool, aligned with its framework, provides quick and optimal navigation through 240 analysis points for risk-based program evaluation. The AMGAIP Report deliverable is a data- and analysis-rich document that provides a summary of the overall program gaps, details of program risk, and serves as a mechanism in selecting key areas of focus and support for prioritized improvement. The AMGAIP Roadmap is constructed on an engineering project plan platform with individual tasks that include sequencing, dependency, assignment, due date, qualification, and duration requirements. This ensures the plan is actionable and measurable in support of a successful implementation. The results are a multi-phased detailed budget and results-focused action plan that includes roles and responsibilities (RACI) of identifying “who implements what” and “how” it is to be implemented.

Maintaining your site network infrastructure in a State of Good Repair is mission-critical to sustain a reliable and efficient supply chain. Triad performs risk-based SGR analysis for a variety of manufacturers across the globe. SGR exists when a pre-defined percentage of site assets are within their useful life, parts obsolescence is being managed, and assets are performing at their designed function. An SGR Vulnerability Analysis begins with analyzing any gaps within your essential physical infrastructure program elements: Engineering, Capital and Maintenance Strategies, Business Processes, and Implementation Plan. This Vulnerability Analysis enables the development of a remediation plan to be addressed via Long Term Capital Planning, Maintenance Strategies, and Asset Operator Care. Together with the AMGAIP, this completes the “Big Picture” understanding of how the assets arrived at their current Physical State Condition and overall State of Good Repair.

After Triad identifies the areas of opportunity and applies the tools to manage the assets, RemTech has the practical knowledge to implement process-related solutions for clients. This means that RemTech can take issues identified by Triad and link those issues to Critical Quality Attributes and develop ways to control and monitor the corresponding Critical Process Parameters. RemTech consultants specialize in project management, serialization, automation, validation, etc. to ensure your project is completed in an efficient and cost-effective manner. 

While each team is successful in their respective areas, partnering together provides a new level of service and experience to every project. By developing program packages that combine the strengths of these two companies, we can offer our clients a custom-built plan that includes the best practices and the best usage of their assets and processes.

Triad offers life cycle asset management services with a focus on cost performance, investment optimization, and program risk. RemTech focuses on project management through validation, serialization, compliance, and regulatory support. Together, our companies can offer you the best opportunities that fit your organization and your needs. 

Learn more about Triad at www.triadunlimited.com.

Contact us today to see how the partnership between RemTech and Triad can benefit you.

Guidance

Everyone needs a little guidance sometimes. As we grow, we need our parents, teachers, and mentors to show us the way. Even in business, we might find ourselves in need of a guide. RemTech is there to guide you and your organization through strategic planning, project management, and serialization system and process audits.

Strategic Planning

When you work with a RemTech consultant, we take into account your goals, ideas, and needs as we form a plan that fits your organization perfectly. We will help you design a plan with achievable goals and realistic steps to meet those goals. The future that you envision for your organization can become a reality with the right plan, and RemTech consultants have the knowledge and experience to formulate that plan.

Project Management

After the planning stage, we move into implementation. Our consultants become a part of your team to manage your project in all aspects, from new construction to purchasing equipment. We work with contractors on your behalf to ensure you are getting the best results. We have experience in a variety of different industries and we put that experience to work for you.

Serialization System and Process Audits

What if you already have a system in place? We can perform audits on your system or process to ensure that you are meeting industry standards. We compare your processes to regulatory requirements and best practices so you can be confident that your serialization and tracking systems are the best that they can be.

So who do you go to for guidance? If you go to RemTech, you can know that our consultants will bring years of experience and knowledge to work for you. RemTech can guide you to where you want to be, contact us today to see how.

RemTech Consultant: Lois Horne

At RemTech, we know we are only as good as our team and we couldn’t be more proud of that team. The consultants and engineers that make up our team set us apart from the competition and build a quality foundation for everything we do. With quality in mind, we’d like to introduce you to Lois Horne, a consultant with an eye for quality.

Dr. Lois Horne has been a consultant with RemTech since 2016 and has proven herself as a vital member of our team. Lois consults in a variety of areas including Quality Assurance/Control, Technical Operations support, Validation, and project management.

Dr. Horne attended Lycoming College where she earned her B.A. in Chemistry with a minor in Biology. After graduating from Lycoming, she went on to earn her Ph.D. in Organic Chemistry from Clemson University. Lois has years of experience working in the pharmaceutical industry with a focus on Quality Assurance and Control.

With her background in chemistry and the mind of an engineer, Lois is perfectly suited to work with both Operations and Quality support. She works with companies to ensure their production processes are in line with FDA regulations and provides remediation for those who have fallen below those standards. Lois also specializes in cleaning and method validation. In everything she does, Lois is focused on ensuring the companies she works with are compliant and safe.

While Lois’ background is primarily in the Quality Control arena, her experience doesn’t stop there. She specializes in different validation areas, including cleaning, method, software, and process. Lois is a project manager with experience in Root Cause Analysis and Program/SOP establishment. She has the experience and knowledge to serve her clients in the best fashion.

Lois brings a unique set of skills to the team at RemTech. She is able to use her background in chemistry to support other consultants as well as her clients. Her personality and work ethic are valuable assets to our team. One of the things she appreciates most about working with RemTech is the network of consultants and engineers that assist and support each other.  We are so thankful that Dr. Lois Horne is a part of our team. She is part of what makes the RemTech difference.