Category: Blog

An archive of RemTech’s blog, case studies and news.

Is a Consultant Right for Me?

As your business grows and changes, the needs of that business will change as well. As new projects, expansions, processes, or regulations vie for your attention, is hiring a consultant right for you? Today we will look at some reasons to hire a consultant and what to consider when looking for a consultant.

Why Do You Need to Hire a Consultant?

There are many advantages to hiring a consultant. Depending on your project, it may make more sense to hire a consultant than to hire a full-time employee. A consultant can be brought in for a specific time that fits your project and budget. Smaller companies may not have the funds to hire a permanent employee with a specific skill set. A consultant will be able to meet that need.

Another benefit to hiring a consultant is that you get an experienced member of your team that can bring in a fresh new perspective. Having someone on your team with an outside perspective can be a valuable asset. A consultant can review your processes and see where improvements can be made.

What to Consider When Hiring a Consultant?

There are many important things to consider when hiring a consultant. The first thing to consider is the consultant’s skill set and knowledge base. It seems like an obvious step but should not be glossed over. By bringing in a consultant, you are looking to add specific skills to your team, so the consultant must reflect those skills.

Another aspect to consider is finding a consultant that has quality recommendations. Understanding the roles they have filled in the past can inform you on whether the consultant would be the best fit for your team.

Finding a consultant with the right personality for your team is another thing to consider. This person is going to be a part of your team for the duration of your project so make sure he or she will be a good fit. A common issue that can arise when hiring a consultant is facing resentment from the permanent staff, so ensuring personalities work well together can ease possible conflict.

RemTech consultants have years of real-world experience and an extensive knowledge base that can be put to work for you. Our consultants are tried and tested and have proven themselves time and again. RemTech is a trusted consultant firm with many consultants, so you can be sure to get a consultant that meets the needs of your organization. Contact us today to get started!

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Starting a Project: Budget, Scope, and Schedule

Starting a Project: Budget, Scope, and Schedule

 

To have a fire, there are three things you need, fuel, heat, and oxygen. These three things make up the “Fire Triangle”. Each aspect is reliant on the other two. Without the right amount of each, at the right times, fire is not sustainable. The same is true when creating and managing a project. The “Project Triangle” is comprised of budget, scope, and schedule. Today we will look at these aspects and how they interact with each other.

Budget

When dealing with large projects, setting a budget is a great starting place. Your budget will depend upon the type of project you are working on but there are a few things that you can count on for every project; labor, materials, and supplies. Then there are costs that may be project-specific, like travel expenses, renting a workspace, or hiring consultants.

Scope

As you plan your project a major consideration is the scope of the project. The scope of a project sets the boundaries and expectations of the project. The scope defines what the project will accomplish and how you plan to accomplish it.

Schedule

The scope shows when things are to be done. A project schedule lays out the project’s timeline, including stages, goals, milestones, and checkpoints.

Working Together

As you start your planning process, it becomes apparent that each part of the Project Triangle relies on the other two. If any one of the three triangle “sides” are adjusted you no longer have a complete triangle. If the budget is reduced then that will affect the schedule and the scope. When a timeline is shortened, either the budget will need to be increased or the scope will have to be reduced. If items are added to the scope, then you will need more time and/or more budget to complete the project. These are key points to remember when planning a project and will help you to successfully accomplish your goal.

 

RemTech has experienced project managers that can construct a Project Triangle that fits your organization and goals. Contact us today to see what we can do for you.

 

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RemTech Consultant: Jason Carpenter

Once again, we are proud to introduce you to another one of our consultants. This month we would like to shine a spotlight on our Director of Engineering, Jason Carpenter.

 

Since graduating from Tennessee Technological University with a Bachelor of Science in Manufacturing and Industrial Technology, Jason has worked as a Project Engineer in various roles in the pharmaceutical and industrial manufacturing industries. Throughout his career, he has managed multiple construction projects and process improvement projects for different firms. Now, in his position as Director of Engineering for RemTech, Jason focuses on facility and process support for pharmaceutical manufacturing operations.

 

One of the things that Jason appreciates about his position is the wide variety of projects, locations, and clients that he has the opportunity to work with. While the project types and locations may change, one thing that remains consistent is his approach to each project. The first things that Jason looks at with a new project are organization and communication. Each is vital for any project, without proper organization and communication the project will struggle to stay within the parameters of the scope, schedule, and budget.

 

Jason is a valuable asset to our organization and he is a leader in his own community. Jason volunteers and holds positions of leadership in multiple organizations in his hometown. While he values his career and the volunteer work that he does, the most important job he has is as a husband and father. He loves spending time camping and enjoying the great outdoors with his family and friends.

 

At RemTech, we understand that our consultants make us who we are. Jason Carpenter is an indispensable part of our team and brings a unique set of skills to serve our clients. We are proud of our consultants and know that they have the skills and knowledge to lead our clients to success. Contact us today to see what our consultants can do for you!

 

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The RemTech Difference: Innovation and Insight

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.

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Serialization, Track and Trace- Knowing the 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.

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The RemTech Difference: Cultivating a Culture

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.

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New Year, New You!

 

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.

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RemTech Consultant: David Burgos

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.

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Leading the Way

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.

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8th Annual UGA/FDA Medical Device Regulation Conference

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.

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