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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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 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.