Regulatory Compliance Associates® will be exhibiting at IME (MD&M) South at the Charlotte Convention Center in Charlotte, NC.

 

Stop by booth # 1534 to meet our experts to learn how we can provide you with a complete solution for any of your regulatory, quality, and compliance needs to help ensure the safety of your product and process. Come speak with RCA’s Executive VP of Medical Device and CTO, Seyed Khorashahi, who will be in attendance.

 

Seyed has more than 25 years of experience leading R&D teams in all aspects of developing safety-critical medical devices. Seyed has held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter, Inc., and has an extensive background in medical device product development, quality systems, regulatory affairs, and mergers and acquisitions. Other core competencies include engineering and business strategy. 

 

Seyed also has significant domain expertise not only in FDA and EU standards but also in software systems and hardware development for medical devices. He has a proven track record of efficiently deploying process improvements with extensive knowledge of 21 CFR 820 and ISO 13485.

 


Use the blue Contact Us form at the bottom of the page to schedule a meeting with Seyed!


 

Tech Theater:

Optimize your Quality System for Software as a Medical Device (SaMD)

 

ime south

 

On Wednesday, June 15th at 11:30 am. We will also be hosting a Tech Theater where Seyed will give a brief overview of what software as a medical device (SaMD) is and then take a look at what is needed to Optimize a Quality System for a SaMD. We also will touch on the different risk categories associated with SaMD as well as the Clinical Evaluation and regulatory submission.

We Will Cover

  • Optimization of Quality Management System for SaMD products from inception to retirement and its alignment to ISO 13485
    • SaMD Realization and Use utilizing IEC 62304, AAMI TIR 45
    • Life Cycle Support Processes
  • Intended purpose of the SaMD (Treat/Diagnose, drive clinical management, or inform Clinical management and its impact on device classification
  • Submission documentation requirements for SaMD algorithm (Traditional or AI / ML)
  • Clinical evaluations, validations, and submissions

 

About IME

The all-new IM Engineering South is the six-in-one advanced design and manufacturing expo designed to give you a comprehensive view of the product lifecycle—from prototype to production. Come explore the latest insights and solutions spanning MedTech, packaging, automation, plastics, design, and processing.

Buyers, executives, and decision-makers attend this show which is the Southeast’s largest design and manufacturing event with the goal of meeting new suppliers and sourcing the latest technologies.

 

About RCA Medical Device Services

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 industry experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such

 

Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates Inc.®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

 

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.

Our network of over 500 FDA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans is fully equipped to handle your unique QA needs.

 

Remediation Support

Regulatory Compliance Associates® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® Inc. a competitive differentiator in the remediation space.

 

Strategic Consulting

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® Inc.’s worldwide experience can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

Our 500 industry and FDA experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

About RCA

Regulatory Compliance Associates®  (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Regulatory Compliance Associates® will be exhibiting at CPhI North America 2022 in Philadelphia with Sterigenics and Nelson Labs. Stop by booths #1328 and #1330 to meet experts from each team to learn how we can provide you with a complete solution for any of your projects. Together we understand your business and are prepared to discuss solutions to your regulatory, quality, compliance, sterilization, and lab testing needs to help ensure the safety of your product and process.

Come speak with RCA’s Executive VP of Pharmaceuticals, Steven J. Lynn, who will be in attendance on Wednesday, May 18th. He has over twenty (20) years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues.


Use the blue Contact Us form at the bottom of the page to schedule a meeting with Steve or Follow the link below!


About CPhI NA

CPhI organizes the most important and widespread series of global pharmaceutical events. Our gatherings are both renowned and revered—but it didn’t start in North America. With massive events throughout Asia, South America, Europe, and beyond…more than 500,000 powerful and respected pharma players from every aspect of the supply chain understand that CPhI is where they connect to learn, grow, and conduct business. With a 30-year tradition and an infrastructure fine-tuned to unite buyers, sellers, and industry trailblazers, we expanded this iconic worldwide events portfolio into the most progressive mega market on earth.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

We are happy to announce that we will be presenting an abstract and exhibiting at this year’s INTERPHEX trade show in New York City from May 24th–26th. 

Come listen to Regulatory Compliance Associates ® Inc.’s Executive Vice President of Pharmaceuticals, Steven J. Lynn, MS, present an analysis of the 483 observations over the past 4 years (2018-2021) and make sure you stop by booth #1753 to speak with us and our partners at Nelson Labs about your company’s quality, regulatory, compliance, and laboratory needs.

Steven J. Lynn

Steven Lynn, MS, will be presenting; A Search for Meaning: Analyzing global FDA 483 Observation trends (2018-2021) where he will go over (1) which sub-groups received the greatest number of violations, and (2) present data-driven best practices to trade show attendees for proactively reducing the potential for violations.


Use the blue Contact Us form at the bottom of the page to schedule a meeting with Steve!


About Interphex 2022

For 40+ years, INTERPHEX has been the premier pharmaceutical, biotechnology, and medical device development and manufacturing event where you can “Experience Science through Commercialization”. Based in New York, INTERPHEX brings over 10,500 global industry professionals and 620+ suppliers together to “Learn It, Experience It, Procure It” through a unique combination of our no-cost technical conference, exhibits, demonstrations, partnering opportunities, and networking events to leverage quality, efficiency, and cost-effectiveness in today’s ever-changing global market.

 

About RCA

Regulatory Compliance Associates® Inc.’s background and experience in the Pharmaceutical industry has helped thousands of companies meet regulatory, compliance, quality assurance, and remediation challenges, in addition to their strategic consulting needs.

With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, RCA offers leading pharmaceutical consultants that can help you navigate through the challenges associated with evolving industry regulations.

Our team of over 500 seasoned FDA, Health Canada and EU compliance consultants and regulatory affairs experts can understand the complexities surrounding the pharmaceutical industry and the unique inner workings of the regulatory process. 

 

Client Solutions

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, RCA® Inc. will guide you through every step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone and we fully understand the complexities of the pharmaceutical and biopharmaceutical industries. Our expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following four regulatory affairs services for pharmaceutical companies.

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand, and just one misstep could mean significant and lasting consequences for your business. At RCA® Inc., we offer the experience and resources necessary to guide you in quality compliance.

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

Remediation 

Regulatory Compliance Associates® Inc. has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

Our Company

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
    • Regional offices in Florida, Colorado and Europe
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

How do you ensure that your pharmaceutical product is tested correctly to get it to market as quickly and safely as possible? You can learn directly from our industry experts in Philadelphia on May 11th and 12th.

Join us for two days full of information and discussion about sterilization and lab testing, from both a microbiological and analytical chemistry perspective, presented by experts from Nelson LabsPDA Expert Advisors, Regulatory Compliance Associates® Inc. (RCA), and Sterigenics.

You can expect to gain a good understanding of the principles of end-to-end sterility assurance, including terminal sterilization and aseptic processing. You will also gain valuable regulatory insights. Additionally, you will learn about the use of various sterilization technologies that are suitable for pharmaceutical products and about extractable and leachable testing for single-use systems (including bioprocessing equipment and pharmaceutical manufacturing) and small-volume parenterals. We’ll wrap up the training by discussing requirements for container-closure-integrity testing, release testing, and stability testing.

The industry experts who will be presenting will cover the following topics:

  • End-to-end sterilization & lab-testing solutions
  • Regulatory agencies’ views on terminal sterilization & aseptic processing
  • Sterilization gas & radiation modalities
  • Sterilization programs
  • Aseptic processing compared to terminal sterilization
  • Aseptic processing’s associated challenges
  • E&L considerations for pharma
    Steven J. Lynn
    Steven J. Lynn
  • E&L for bioprocessing equipment & single-use systems
  • E&L for small-volume parenteral applications
  • Container-closure-integrity testing
  • Phase-appropriate method validation
  • Release & stability testing requirements for parenteral drug products

Steven J. Lynn, MS, RCA’s Executive Vice President of Pharmaceuticals, will be presenting on the Regulatory Agencies’ View on Terminal Sterilization & Aseptic Processing on Wednesday at 9:30 am. 


Use the blue Contact Us form at the bottom of the page to schedule a meeting with Steven Lynn!


Registration deadline is April 29, 2022

About RCA

Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

About Nelson Labs

Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology and analytical chemistry testing industry, offering more than 800 laboratory tests and employing more than 500 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it is our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.

Companies choose Nelson Labs for:

  • Thought leaders and approachable experts. We give you direct access to industry authorities who understand your business and add value every step of the way.
  • Customer-centric culture. We take the time to understand your vision. Your goals become our goals.
  • Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.
  • Metric-driven testing processes. We’re our own toughest customer, holding ourselves to goals exceeding 99% for things that matter most to you, like quality, turnaround time, and testing accuracy.
  • Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.

See how we can help you mitigate risk, be first to market, and succeed with your customers.

About Sterigenics

Sterigenics is a leading global provider of outsourced terminal sterilization services for the medical device, pharmaceutical, food safety and advanced applications markets. Across our 48 global facilities, we offer our customers a complete range of sterilization services, primarily using the three major technologies: gamma irradiation, ethylene oxide processing and electron beam irradiation as well as nitrogen dioxide sterilization and x-ray irradiation. We are committed to addressing the growing need for sterilization across the world and partnering with our customers to eliminate threats to human health. Learn more about Sterigenics at www.sterigenics.com

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

pda annual meetingJoin Regulatory Compliance Associates® Inc. (RCA) and Nelson Labs at Booth 307 and 309 during the 2022 PDA Annual Meeting in Dallas this year. The conference will focus on the theme “Level Up: Agility in the New Normal!” and will highlight what’s in store for the future of pharmaceutical manufacturing. Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes.

There are interactive sessions and tracks designed for manufacturing leaders, technical experts/scientists, and early career professionals. No matter what your area of focus, you are sure to come away with tangible, practical solutions to improve your operations and your standing within your company.

 

Steven J. Lynn

Steven Lynn, MS, RCA’s Executive Vice President of Pharmaceuticals, will be presenting in the Quality and Regulatory Track at 10:45 AM-12:15 PM on Wednesday. The presentation titled: Analyzing global FDA 483 Observation trends (2018-2020) will discuss (1) which sub-groups received the greatest number of violations, and (2) present data-driven best practices to trade show attendees for proactively reducing the potential for violations.

 


Use the blue Contact Us form at the bottom of the page to schedule a meeting with Sue or Steve!


“The year over year data trends seem to continually repeat. Like the movie Groundhog Day, the same thing over and over and over. What can we do as an industry to get better and make meaningful change.”

– Steven J. Lynn

 

Susan Schniepp

The PDA Board of Directors Chair and our Distinguished Fellow, Susan Schniepp, will be kicking off the event during the welcome event. She will also bring her expert perspective to the panel discussions with her 40+ years of quality consulting expertise.

 

2022 PDA Annual Meeting Exhibit Hours

Monday, April 4th, 2022 | 5:00PM to 6:30PM

Tuesday, April 5th, 2022 | 9:45AM to 4:00PM

Wednesday, April 6th, 2022 | 9:45AM to 1:45PM

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

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