Author: Bob Matje

Robert “Bob” Matje, PE, CPIP, has held increasing levels of responsibility in several branded and generic pharmaceutical companies including general management. He has also lead reliability and maintenance, environmental, health and safety, automation, capital and qualification teams and served as the Serialization Project Management Office (PMO) Lead for Endo and for Pfizer, which included responsibility for establishing the serialization governance, scope development, schedule and cost. Bob is a member of the International Society of Pharmaceutical Engineering (ISPE) and was recently elected to his second term on ISPE’s International Board of Directors. Bob earned a BS in Engineering at Lafayette College and an MS in Engineering at Villanova University. He is a Registered Professional Engineer in Pennsylvania and was awarded his Certified Pharmaceutical Industry Professional certification in 2012.

Guidance

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.

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RemTech Consultant: Lois Horne

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.

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The DSCSA: What You Need to Know

 

November 27, 2023, is coming and it will be here before we know it. What’s so important about this date? It’s the date that the Drug Supply Chain Security Act (DSCSA) will be completely phased in. As pharmaceutical companies work to reach full compliance, here’s a quick refresher on the DSCSA.

 

What is the DSCSA?

 

The Drug Supply Chain Security Act lays out the requirements that everyone involved in the pharmaceutical supply chain must follow. This includes all manufacturers, repackagers, distributors, dispensers, and trading partners. The purpose of the DSCSA is to provide an interoperable system that will be able to track and trace prescription drugs as they are manufactured and distributed across the United States.

 

What are the benefits?

 

The DSCSA provides the FDA with the resources to better protect consumers against counterfeit drugs by tracking those drugs through the various stages of production. By building a system to track prescription drugs, the FDA and manufacturers will be better equipped to detect and remove potentially hazardous drugs before they get to the consumer.

 

What do I need to do?

 

The first step is to be familiar with the law. After you are familiar with your responsibilities laid out in the DSCSA, work with your trading partners to ensure that they know their roles.

A great way to make sure you are compliant with all the new regulations is to partner with a company that specializes in compliance and validation. RemTech consultants are experts in DSCSA laws and know what it takes to make sure you are compliant. Our consultants work to make you compliant through project management, staff augmentation, validation.

 

Don’t let the DSCSA deadline sneak up on you. We would love to answer any questions you may have and set you on the right path. Contact us today.

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RemTech Consultants: Johnny Colvin

 

At RemTech, we know that it’s our consultants that make us great. With that in mind, we would like to introduce you to one of our great consultants, Johnny Colvin.

 

Johnny is a Senior Project Manager Consultant and has been with RemTech since 2018. As a Senior Project Manager Consultant, Johnny provides consultation on Validation, Serialization, Track and Trace Supply Chain B2B, and DSCSA compliance. He is also Fanuc Robotics trained in Handling Tool operations and programming.

 

After graduating from Alabama A&M University with a Bachelor of Science in Mechanical Engineering Technology, Johnny earned his Master of Science in Management of Information Systems at the University of Phoenix.

 

Before joining our team at RemTech, Johnny spent over a decade working in the pharmaceuticals industry overseeing validation activities and managing serialization infrastructure developing projects. Johnny’s main focus is to ensure his clients maintain compliance with current laws, FDA regulations, and industry standards.

 

While Johnny loves working with and supporting his clients, he balances his work with time with his family. He spends his free time playing with his granddaughter or working on fixing up cars. Johnny played baseball in college and loves to attend sporting events whenever possible and spends the off-season playing sports video games.

 

At RemTech, we are privileged to work with engineers and consultants like Johnny. We are dedicated to our team and strive to create a workplace that fosters creativity and vision. When we asked Johnny what he loves about RemTech he said “The culture and the owners are awesome. I love the RemTech team because everyone shares the same vision and is dedicated to the mission. I have a great degree of control and freedom within my job. I like the autonomy I have because my bosses allow me to innovate.”

 

We are proud to introduce you to Johnny Colvin- Inspiring Role Model, Sports video game player, Car Connoisseur, RemTech Consultant

 

 

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The Right Way

The Right Way

When starting a project, many people will tell you what you need to do. You will hear a lot of opinions on what is the “right” way. But what is the right way? The right way to complete a task or project is the way that works for you, and at RemTech, we will help you get there. RemTech has the right team for the right job to ensure your project is done the right way.

The Right Team

At RemTech, our consultants are the right choice for your team. We have experience in many different industries including pharmaceuticals, food, engineering, general industrial manufacturing, construction. We bring that experience to work for you to ensure that your project is completed in an efficient and professional manner. RemTech consultants work as a part of your team, listening, training, and teaching your team as we work to complete your project.

The Right Job

We have the professional experience you need, but that’s just half of it. The other half is the technical know-how to get the job done. We work with organizations to ensure you stay current with all federal, state, and local regulations. We help you create and maintain documentation for the equipment that you use in your facility. For many organizations, we assist in the acquisition and installation of new equipment. At RemTech, we work with your team to develop Standard Operating Procedures to ensure that, even after we’re done, your project can continue to maintain and run smoothly and effectively.

The Right Way

Every business is different, so to make sure that your business is working in the right way we will develop a plan that is suited to your individual needs and goals. Your success is our priority. When you partner with RemTech, you partner with consultants and engineers that focus on your project and the right way for you.

When you are starting a project, do it the right way. Start with the right team to do the right job. Start with RemTech and get things done the right way.

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It’s All Coming Together

It’s All Coming Together

A well-functioning machine can have many moving parts. Each of those parts has to work in conjunction with the other parts to make a machine that fulfills its designed purpose. If one part of an engine isn’t working properly, it affects the whole vehicle. In the same manner, all of the different pieces of equipment in your facility need to work correctly and synchronistical to ensure that your manufacturing process is functioning properly. At RemTech, we specialize in many areas. One of those areas is validation and qualification with a focus on the unique aspects and needs of your business.

 

Validation

While working with an organization, we work hand in hand with Quality, Technical, and Validation teams to produce documentation on the equipment that the facility uses or has recently purchased.

 

Installation Qualification

The Installation Qualification documents record information pertaining to the equipment in use, such as serial numbers, model numbers, voltage, etc. to be sure what was installed is what was expected to be installed. This document verifies that the equipment has been installed correctly and meets the standards set forth by the manufacturer and installation guidelines.

Operational Qualification

The Operational Qualification documents verify and record that the equipment is in proper working order. Tests are completed to ensure that the equipment operates as expected and according to the manufacturer’s specifications.

Standard Operating Procedures

Standard Operating Procedures, or SOP, provide users with directions on proper usage for each piece of equipment. These documents are specifically written to reflect the needs and operations of your company.

Preventative Maintenance

Preventative Maintenance documents are written for each piece of equipment. The PMs plan out maintenance for the equipment based on the manufacturer’s guidelines. PMs also take into account the usage of the machine so that the maintenance fits with the schedule of your facility.

At RemTech, we are focused on making sure your company runs like a well-oiled machine. Through validation and documentation, we work with your company to provide all the necessary resources that you will need for success.

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Writing Your Success Story

Every story has a beginning. A place to start. The story of your business starts with you. Your dreams, your goals, your aspirations, all make up your story. How do you make sure that your story leads to success? By partnering with a company that knows success. RemTech brings over ninety years of combined experience to guarantee your success. Through strategic planning, project management, and operational implementation, we will help you write your story of success.

Strategic Planning

Our consultants with work with you to analyze the individual needs of your company or project. We will identify any potential issues and develop a strategy to resolve those issues. Our team will work with you to establish a budget and timeline for completion.

Project Management

As experienced project managers, we will handle your project in a professional and timely manner. We specialize in the management of construction, renovation, procuring and installing new equipment, and many other areas. RemTech consultants can work as your representative while dealing with contractors to make sure you are getting the best quality work done for the best price.

Operational Implementation

We will assist you in creating a plan and in making that plan a reality, but we don’t stop there. We work to make sure that the implementation of your new project or process smooth and successful. Through staff augmentation, our consultants become a part of your team. We will also build teams and provide training to ensure your project’s success.

RemTech has years of experience writing success stories. When you join us, you can be assured that we will work tirelessly to guarantee the success of your project or process.

So what kind of story are you writing? Write a story of success, write your story with RemTech.

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The RemTech Difference

The RemTech Difference

There are many consultants out there but none like the RemTech consultant. Our team of professional consultants can make the impact that you are needing. We take pride in leading the industry in technical services, compliance, and project management. Here is what makes our consultants different.

Technical Services

Our consultants are skilled in a variety of technical areas to ensure your needs are met. We have experienced manufacturing and business management professionals that are focused on your success. Our team strives to provide you with effective solutions to even the most challenging issues.

Compliance & Regulatory

One of the most important aspects of our business is staying current in industry trends and regulatory compliance. RemTech consultants can guarantee that your business falls within the bounds of all federal, state, and local regulations. We have a “right-first-time” approach that is highly cost-effective and streamlines your success.

Project Management

Whether you are upgrading your production system, building a new facility, researching and purchasing new equipment, or starting another new project, our consultants specialize in project management. We will work with your team to make sure your project is completed in an efficient manner. You can trust RemTech consultants to manage projects for you so you will be free to focus on other aspects of your business.

When you partner with RemTech, you get more than just a consultant. You get a team with decades of knowledge and experience. We put that knowledge and experience to work for you. Our success is measured by your success. Ensuring your satisfaction is our goal and we won’t rest until the job is done.

Contact us today to see the difference that RemTech can make.

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Growing Pains

Remember when you were a kid and couldn’t wait to grow up? Grownups could stay up as late as they wanted, they didn’t have homework, they could even have ice cream before dinner if they wanted. Being a grownup was the dream. As most of us know, we may be able to have ice cream whenever we want, but growing up also provides us with new challenges and opportunities that we didn’t know about as children.

The same is true for your growing business. Challenges and opportunities come naturally with growth. At RemTech, we want to be there to help you overcome whatever comes your way.

One challenge that many growing businesses will face is utilizing the space to best support your operation and processes. As your business grows, so will your need for stockrooms, workspaces, and warehouses.  That’s where RemTech comes in. If you need to expand or modify the facility, we specialize in construction management to make sure you have the workspace to get the job done.

RemTech consultants have experience in construction management from preliminary planning to execution to project completion. We work as your representative, working with engineering firms and contractors to make sure that the work is done within budget and, more importantly, correctly. We coordinate with trade workers, such as electrical, mechanical, and plumbing, as well as specialty services, like security and fire alarm systems, to ensure your building meets all state and local building codes.

The most important thing to remember is that you have a growing business to run. You may not have the resources or time to devote to a new building project. Why not work with a company that knows the ins and outs of construction management and can handle your project from start to finish? We have the resources, connections, and experience needed to successfully handle any building project. Whether we work as consultants or project managers, we will work to provide you with a new facility that meets the needs of your expanding business.

As your business grows, new challenges will arise. Will you be ready? RemTech can make sure you are ready to face these opportunities and succeed. Contact us for a consultation today.

 

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From Ideas to Implementation

You have an idea. You’ve laid the foundation, you’ve set goals, and you’re ready to start your project. The next step is moving your project from an idea to a reality. RemTech specializes in project management and implementation. We put our years of expertise and knowledge to work for you to ensure the success of your project. From space utilization to procuring equipment to staff augmentation, the professionals at RemTech have the experience to help you succeed.

 

Space Utilization

 

The layout of your facility or workspace can have a significant impact on your productivity and overall workflow. The efficient placement of equipment, workstations, and production lines can bolster productivity while cutting down on wasted space and downtime. RemTech consultants will work with you to design a layout that will benefit your individual facility and maximize your space.

 

Procuring Equipment

 

Buying and upgrading equipment can be a daunting task. Verifying that you are getting the correct equipment for your facility or project while balancing quality versus price can be a challenge. RemTech consultants are up to that challenge. We have an in-depth knowledge of production equipment and the experience to know what will work best for you. We work with companies to upgrade and install new equipment while ensuring they receive the best value possible.

 

Staff Augmentation

 

For some projects, having a consultant may not be enough. In those cases, RemTech can provide staff augmentation to help meet your needs. Our consultants can be placed in your facility as a full-time member of your team. Our consultants can work with you on a daily, in-person basis to oversee the project and meet any needs that arise. Having a RemTech consultant as a long term team member provides the experience that you need without the need for an outside hire.

 

At RemTech, we want to see your project succeed and thrive. Joining with RemTech gives you and your team smart solutions to manage your business and project. Let us help you turn your ideas into reality. Contact us today to start your next project.

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